Continua Personal Health Device Data Implementation Guide

Phg Device JSON Example

Phg Device Profile

The properties and specifications of the PHG are reported in a Device resource. A PHG does not have an MDS object, but for the purposes of reporting the PHG information, like its system identifier, time synchronization, and serial number, these values are treated as if they came from MDS-attributes in an MDS object. These 'mock' attributes and object are not required to exist on the PHG.

Unlike the PHD where one reports the information if delivered, in the PHG case far fewer fields are required to be reported. The following table summarizes the required 'MDS' fields and their mappings:

'PHG MDS' field	Device element
System Identifier	identifier
Time sync protocol	property

For Continua compliance, the values in the mock Reg-Cert-Data-List shall be included:

'Continua PHG MDS' field	Device element
Continua Version	version
Certified PAN Interfaces	property
Certified H&FS Interfaces	property
Regulation status	property

A transport address is not required. It is still strongly recommended that the transport address is reported as it is often beneficial to consumers. Most PHD-PHG transports provide a means of obtaining a transport address or an equivalent identifier such as a USB VID and PID. In addition, it may be beneficial to report the transport address of the H&FS interface as well, such as the MAC address.

Similar to the PHD case, when CodeableConcept data types are used it is recommended to put the MDC reference identifier as part of the display element when the system element indicates the MDC coding system "urn.iso.std.iso:11073:10101".

The structure definition for the Phg Device Profile is shown below:

DeviceComponent	I		DeviceComponent	Element id DeviceComponent Short description An instance of a medical-related component of a medical device Definition The characteristics, operational status and capabilities of the PHG. Comments Unlike the PHD, there is only a single resource representing the PHG. This resource is referenced by the phdParentDeviceComponent. Data type DeviceComponent Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative `contained.text.empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource `contained.where(('#'+id in %resource.descendants().reference).not()).empty()` Mappings rim: Entity. Role, or Act w5: administrative.device
id	Σ	0..1	id	There are no (further) constraints on this element Element id DeviceComponent.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type id Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
meta	Σ	1..1	Meta	There are no (further) constraints on this element Element id DeviceComponent.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id DeviceComponent.meta.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceComponent.meta.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
versionId	Σ	0..1	id	There are no (further) constraints on this element Element id DeviceComponent.meta.versionId Short description Version specific identifier Definition The version specific identifier, as it appears in the version portion of the URL. This values changes when the resource is created, updated, or deleted. Comments The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes. Data type id Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
lastUpdated	Σ	0..1	instant	There are no (further) constraints on this element Element id DeviceComponent.meta.lastUpdated Short description When the resource version last changed Definition When the resource last changed - e.g. when the version changed. Comments This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. Data type instant Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
profile	Σ	1..*	uri	Element id DeviceComponent.meta.profile Short description Profiles this resource claims to conform to Definition A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url. Comments It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set. Data type uri Sliced: Unordered, Open, by PhgDeviceComponent(Value) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
phgProfile	Σ	1..1	uriFixed Value	Element id DeviceComponent.meta.profile:phgProfile Short description Profiles this resource claims to conform to Definition A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url. Comments It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Fixed value PhgDeviceComponent Mappings rim: n/a
security	Σ	0..*	CodingBinding	There are no (further) constraints on this element Element id DeviceComponent.meta.security Short description Security Labels applied to this resource Definition Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure. Comments The security labels can be updated without changing the stated version of the resource The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored. Data type Coding Binding Security Labels from the Healthcare Privacy and Security Classification System. ?? (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
tag	Σ	0..*	Coding	There are no (further) constraints on this element Element id DeviceComponent.meta.tag Short description Tags applied to this resource Definition Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource. Comments The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored. Data type Coding Binding Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones" ?? (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id DeviceComponent.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id DeviceComponent.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. ?? (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
text	I	0..1	Narrative	There are no (further) constraints on this element Element id DeviceComponent.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id DeviceComponent.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Data type Resource Mappings rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	Element id DeviceComponent.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
MyExtension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceComponent.extension:MyExtension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id DeviceComponent.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier	Σ	1..1	Identifier	Element id DeviceComponent.identifier Short description Information that uniquely describes the PHG Definition The locally assigned unique identification of the device that is semantically meaningful outside of the FHIR resource context. An example would be the IEEE EUI-64 System-Id or transport address. For PHGs the systemIdentifier is required and the transportAddressIdentifier is highly recommended as this is what most end users see and can obtain from the PHG itself or PHG packaging. Comments In future versions of FHIR the cardinality of this element will become [0..] and this element will be used to report the system id and optionally the transport address. Data type* Identifier Sliced: Ordered, Open, by system(Value) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: id
systemIdIdentifier	Σ	1..1	Identifier	Element id DeviceComponent.identifier:systemIdIdentifier Short description IEEE EUI-64 identifier Definition This entry contains the IEEE EUI-64. If absent set to all zeros. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: id
id		0..1	string	There are no (further) constraints on this element Element id DeviceComponent.identifier:systemIdIdentifier.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceComponent.identifier:systemIdIdentifier.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id DeviceComponent.identifier:systemIdIdentifier.use Short description usual \| official \| temp \| secondary (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . ?? (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id DeviceComponent.identifier:systemIdIdentifier.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. ?? (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD v2: CX.5 rim: Role.code or implied by context
system	Σ	1..1	uriFixed Value	Element id DeviceComponent.identifier.system Short description IEEE EUI-64 identifier Definition Identifies the system as an IEEE EUI. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Fixed value urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680 Mappings rim: n/a v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	Σ	1..1	string	Element id DeviceComponent.identifier.value Short description The value that is unique Definition The System id as an 8-byte HEX string where each byte is separated by dashes, for example FE-ED-AB-EE-DE-AD-77-C3. Comments The formatting is specified in the IEEE document Guidelines for 64-bit Global Identifier. To allow the mapping of naughty, non-compliant proprietary devices that do not provide a system id, the value is set to all zeros in the same format, 00-00-00-00-00-00-00-00 Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Examples General 123456 Mappings rim: n/a v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value
period	Σ I	0..1	Period	There are no (further) constraints on this element Element id DeviceComponent.identifier:systemIdIdentifier.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Comments This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). If duration is required, specify the type as Interval\|Duration. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` per-1: If present, start SHALL have a lower value than end `start.empty() or end.empty() or (start <= end)` Mappings rim: n/a v2: DR rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ I	0..1	Reference(http://hl7.org/fhir/StructureDefinition/Organization)	There are no (further) constraints on this element Element id DeviceComponent.identifier:systemIdIdentifier.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(http://hl7.org/fhir/StructureDefinition/Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
transportAddressIdentifier	Σ	0..1	Identifier	Element id DeviceComponent.identifier:transportAddressIdentifier Short description Transport address identifier Definition This entry contains the transport address, for example the Bluetooth, ZigBee, USB, or mac address. Comments USB does not have an 'address' as it is a point to point wired protocol. However, it does have a Vendor identification and Production identification number which together uniquely define the unit. For USB transports, the VID.PID in HEX is used as the transport identifier. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier w5: id
id		0..1	string	There are no (further) constraints on this element Element id DeviceComponent.identifier:transportAddressIdentifier.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceComponent.identifier:transportAddressIdentifier.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
use	Σ ?!	0..1	codeBinding	There are no (further) constraints on this element Element id DeviceComponent.identifier:transportAddressIdentifier.use Short description usual \| official \| temp \| secondary (If known) Definition The purpose of this identifier. Requirements Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Comments This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Data type code Binding Identifies the purpose for this identifier, if known . ?? (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: N/A rim: Role.code or implied by context
type	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id DeviceComponent.identifier:transportAddressIdentifier.type Short description Description of identifier Definition A coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Requirements Allows users to make use of identifiers when the identifier system is not known. Comments This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. Data type CodeableConcept Binding A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. ?? (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD v2: CX.5 rim: Role.code or implied by context
system	Σ	1..1	uri	There are no (further) constraints on this element Element id DeviceComponent.identifier.system Short description The namespace for the identifier value Definition Establishes the namespace for the value - that is, a URL that describes a set values that are unique. Requirements There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Examples General http://www.acme.com/identifiers/patient Mappings rim: n/a v2: CX.4 / EI-2-4 rim: II.root or Role.id.root servd: ./IdentifierType
value	Σ	1..1	string	Element id DeviceComponent.identifier.value Short description The value that is unique Definition The transport address. If Bluetooth, use an EUI-48 such as 00-E5-DE-AD-77-C3. If a USB device use the VID.PID as HEX such as 0043.F90D. If a ZigBee address use an EUI-64 as with the system id. If a TCP/IP address use the standard IP address format such as 192.168.127.4 Comments Transport addresses are supposed to be unique for a given device. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Examples General 123456 Mappings rim: n/a v2: CX.1 / EI.1 rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root) servd: ./Value
period	Σ I	0..1	Period	There are no (further) constraints on this element Element id DeviceComponent.identifier:transportAddressIdentifier.period Short description Time period when id is/was valid for use Definition Time period during which identifier is/was valid for use. Comments This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). If duration is required, specify the type as Interval\|Duration. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` per-1: If present, start SHALL have a lower value than end `start.empty() or end.empty() or (start <= end)` Mappings rim: n/a v2: DR rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"] v2: CX.7 + CX.8 rim: Role.effectiveTime or implied by context servd: ./StartDate and ./EndDate
assigner	Σ I	0..1	Reference(http://hl7.org/fhir/StructureDefinition/Organization)	There are no (further) constraints on this element Element id DeviceComponent.identifier:transportAddressIdentifier.assigner Short description Organization that issued id (may be just text) Definition Organization that issued/manages the identifier. Comments The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization. Data type Reference(http://hl7.org/fhir/StructureDefinition/Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) v2: CX.4 / (CX.4,CX.9,CX.10) rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper servd: ./IdentifierIssuingAuthority
type	Σ	1..1	CodeableConceptBinding	Element id DeviceComponent.type Short description What kind of component it is Definition States that this is a Personal Health Gateway (PHG) formally known as an AHD Comments There is a special 11073 code that indicates a PHG. It's reference id was made at the time PCHA (then Continua) called a PHG an AHD and since the id is in the system it cannot be changed. Data type CodeableConcept Binding Describes the type of the component. ?? (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD w5: class
id		0..1	string	There are no (further) constraints on this element Element id DeviceComponent.type.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceComponent.type.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	Σ	1..*	Coding	Element id DeviceComponent.type.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Sliced: Ordered, Open, by system(Value) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
11073Type	Σ	1..1	Coding	Element id DeviceComponent.type.coding:11073Type Short description Code defined by a terminology system Definition The 11073 10101 code for the PHD specialization. Requirements Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings. Comments This coding is provided by the System-Type-Spec-List attribute. Note that PoCDs do not have a System-Type-Spec-List but express specializations in different VMD objects. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id DeviceComponent.type.coding:11073Type.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceComponent.type.coding:11073Type.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	Σ	1..1	uriFixed Value	Element id DeviceComponent.type.coding.system Short description Identifies IEEE 11073 10101 Definition This value identifies the IEEE 11073 10101 coding system Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Fixed value urn:iso:std:iso:11073:10101 Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id DeviceComponent.type.coding:11073Type.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	1..1	codeFixed Value	Element id DeviceComponent.type.coding.code Short description PHG code Definition The code indicating the entity is a PHG Requirements There is only one possible entry as there is only a single type of PHG Comments The reference id for this code is MDC_MOC_VMS_MDS_AHD Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Fixed value 531981 Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	Element id DeviceComponent.type.coding.display Short description Representation defined by the system Definition A human readable display descrbing the meaning of the code. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments This element should contain the reference identfier for the reported specialization code. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id DeviceComponent.type.coding:11073Type.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	0..1	string	There are no (further) constraints on this element Element id DeviceComponent.type.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
lastSystemChange	Σ	0..0	instant	Element id DeviceComponent.lastSystemChange Short description Recent system change timestamp Definition The timestamp for the most recent system change which includes device configuration or setting change. The PHG is static. Comments A PHG is static and does not change. The absence of this element indicates a static unit. Data type instant Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a w5: when.init
source	Σ I	0..0	Reference(http://hl7.org/fhir/StructureDefinition/Device)	Element id DeviceComponent.source Short description Top-level device resource link Definition The link to the source Device that contains administrative device information such as manufacture, serial number, etc. Comments PHGs are a gateway for PHD data and are not a subset of any further entity by protocol. Data type Reference(http://hl7.org/fhir/StructureDefinition/Device) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
parent	Σ I	0..0	Reference(http://hl7.org/fhir/StructureDefinition/DeviceComponent)	Element id DeviceComponent.parent Short description Parent resource link Definition The PHG is at the top and has no parent. Requirements The PHG serves as a gateway for the PHD data. It has no parent in the sense of a PoCD hierarchy. Comments This element shall not be present. Data type Reference(http://hl7.org/fhir/StructureDefinition/DeviceComponent) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
operationalStatus	Σ	0..*	CodeableConceptBinding	Element id DeviceComponent.operationalStatus Short description Current operational status of the component, for example On, Off or Standby Definition The current operational status of the device. For example: On, Off, Standby, etc. Comments OperationalStatus for the MDS, VMD, or Channel will be bound to a specific ValueSet that is defined in its profile. If used, a PHD is considered to be always on Data type CodeableConcept Binding Codes representing the current status of the device - on, off, suspended, etc. ?? (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
parameterGroup	Σ	0..1	CodeableConceptBinding	Element id DeviceComponent.parameterGroup Short description Current supported parameter group Definition The parameter group supported by the current device component that is based on some nomenclature, e.g. cardiovascular. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. This information is not available by protocol from the PHD and its use is up to the application. Data type CodeableConcept Binding Codes identifying groupings of parameters; e.g. Cardiovascular. ?? (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
measurementPrinciple	Σ	0..1	codeBinding	Element id DeviceComponent.measurementPrinciple Short description other \| chemical \| electrical \| impedance \| nuclear \| optical \| thermal \| biological \| mechanical \| acoustical \| manual+ Definition The physical principle of the measurement. For example: thermal, chemical, acoustical, etc. Comments This information is not available fron PHD devices by protocol. Its use is up to the implementation. Data type code Binding Different measurement principle supported by the device. ?? (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
productionSpecification	Σ	0..*	BackboneElement	Element id DeviceComponent.productionSpecification Short description Specification details such as Component Revisions, or Serial Numbers Definition The production specification such as component revision, serial number, etc. For the 11073 20601 Personal Health Device, the production specification entries come from the Production-Specification, System-Model, and Reg-Cert-Data-List attributes. There will be one productionSpecification entry for each item to be reported. Comments All the PHD productionSpecification entries are strings and have IEEE 11073-10101 codes that define which production specification the string represents. Compliant PHDs will always have at least some entries for this element. If the PHD reports one or more such entries, they shall be recorded here. However, to allow the mapping of naughty proprietary devices, this element is made technically optional. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
specType	Σ	1..1	CodeableConceptBinding	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType Short description Type or kind of production specification, for example serial number or software revision Definition The specification type, such as, serial number, part number, hardware revision, software revision, etc. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Codes for device specification types such as serial number, part number, hardware revision, software revision, etc. ?? (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
id		0..1	string	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	Σ	1..*	Coding	Element id DeviceComponent.productionSpecification.specType.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Sliced: Ordered, Open, by system(Value) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
11073Type	Σ	1..1	Coding	Element id DeviceComponent.productionSpecification.specType.coding:11073Type Short description The 11073-10101 code Definition The 11073-10101 code defining what the productionSpec is Requirements Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings. Comments 11073 10101 codes have been defined for the Production-Specification and System-Model sub entries for use in V2 messaging. Though FHIR has provided its own set of codes based upon the names of the 11073-* Production-Specification.spec-type entry, the 11073-10101 codes are used since they are ubiquitous in these PCHA-related profiles and it helps accelerate the acceptance of the MDC coding system in HL7. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType.coding:11073Type.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType.coding:11073Type.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	Σ	1..1	uriFixed Value	Element id DeviceComponent.productionSpecification.specType.coding.system Short description Specifies IEEE 11073 10101 Definition Identifies the IEEE 11073 10101 coding system Requirements Need to be unambiguous about the source of the definition of the symbol. Comments These codes are not seen on the wire between the PHD and the PHG. They are seen on the wire in PCD-01 messages. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Fixed value urn:iso:std:iso:11073:10101 Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType.coding:11073Type.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	1..1	code	Element id DeviceComponent.productionSpecification.specType.coding.code Short description actual code Definition The 32 bit code identifying what the string in the DeviceComponent.productionSpecification.productionSpec element is. Requirements Need to identify what the reported string value represents Comments The currently defined codes used in this element are as follows: FIELD CODE reference identifier Model number 531969 MDC_ID_MODEL_NUMBER Manufacturer name 531970 MDC_ID_MODEL_MANUFACTURER The above come from the 'pretend' System-Model attribute Unspecified 531971 MDC_ID_PROD_SPEC_UNSPECIFIED Serial number 531972 MDC_ID_PROD_SPEC_SERIAL Part number 531973 MDC_ID_PROD_SPEC_PART Hardware revision 531974 MDC_ID_PROD_SPEC_HW Software revision 531975 MDC_ID_PROD_SPEC_SW Firmware revision 531976 MDC_ID_PROD_SPEC_FW Protocol 531977 MDC_ID_PROD_SPEC_PROTOCOL Global Medical Device Nomenclature (GMDN) 531978 MDC_ID_PROD_SPEC_GMDN The above come from the 'pretend' Production-Specification attribute Continua version 532352 MDC_REG_CERT_DATA_CONTINUA_VERSION The above comes from the 'pretend' Continua Reg-Cert-Data-List attribute There may be more fields added in future versions of the 10101 specification. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	Element id DeviceComponent.productionSpecification.specType.coding.display Short description Representation defined by the system Definition A human readable display descrbing the meaning of the code. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments This element should contain the reference identfier for the reported code. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType.coding:11073Type.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
fhirCoding	Σ	0..1	Coding	Element id DeviceComponent.productionSpecification.specType.coding:fhirCoding Short description The IEEE concept in the DeviceSpecificationSpecType coding system Definition THe IEEE concept defined in the 11073Type coding element expressed in the DeviceSpecificationSpecType coding system. Requirements Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings. Comments FHIR requires this element to be present IF the production specification being reported is included in the DeviceSpecificationSpecType value set. Currently that is all the possible entries defined in the IEEE 11073 ProductionSpecification attribute. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType.coding:fhirCoding.id Short description xml:id (or equivalent in JSON) Definition unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType.coding:fhirCoding.extension Short description Additional Content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	Σ	1..1	uriFixed Value	Element id DeviceComponent.productionSpecification.specType.coding:fhirCoding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Fixed value http://hl7.org/fhir/specification-type Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType.coding:fhirCoding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	1..1	code	Element id DeviceComponent.productionSpecification.specType.coding:fhirCoding.code Short description Symbol in syntax defined by the system Definition A symbol in the syntax defined by the DeviceSpecificationSpecType system. Requirements Need to refer to a particular code in the system. Comments FHIR requires this code if the specType being coded is a member of this value set. Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType.coding:fhirCoding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType.coding:fhirCoding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	0..1	string	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.specType.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
componentId	Σ	0..1	Identifier	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.componentId Short description Internal component unique identification Definition The internal component unique identification. This is a provision for manufacture specific standard components using a private OID. 11073-10101 has a partition for private OID semantic that the manufacturer can make use of. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier
productionSpec	Σ	1..1	string	There are no (further) constraints on this element Element id DeviceComponent.productionSpecification.productionSpec Short description A printable string defining the component Definition The printable string defining the component. Comments Note that FHIR strings may not exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a
languageCode	Σ	0..1	CodeableConceptBinding	Element id DeviceComponent.languageCode Short description Language code for the human-readable text strings produced by the device Definition The language code for the human-readable text string produced by the device. This language code will follow the IETF language tag. Example: en-US. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. This infomration is not available by protocol from the PHD and its use is up to the application Data type CodeableConcept Binding A human language. ?? (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() \| (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD

A JSON example is given in Phg Device JSON Example

Meta Data Profile

The uploader shall populate the Device.meta.profile with http://pchalliance.org/phdfhir/StructureDefinition/PhgDevice indicating this resource is generated following this PHD Implementation Guide.

System Identifier

All 11073 20601 PHGs are required to have a system identifier. It is an EUI-64 consisting of 8 bytes. The system id is mapped to the Device.identifier.value element as a sequence of 8 2-digit bytes as HEX separated by dashes without the '0x' prefix commonly used in programming languages. An example of such a string is FE-ED-AB-EE-DE-AD-77-C3. It shall be reported.

It is strongly encouraged to also report the PHG PAN and H&FS transport addresses in a second and third identifier element. The transport addresses are as follows:

transport	format	example
Bluetooth	EUI-48	00-E5-DE-AD-77-C3
ZigBee	EUI-64	36-ED-9A-EE-DE-AD-77-C3
USB	vid.pid	0043.F90D
MAC	EUI-48	EE-FF-DE-AD-77-01

The identifier for the system id:

identifier.value=system id formatted as above
identifier.system="urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680"
identifier.use="official"
identifier.assigner.display="EUI-64

The identifier for the Bluetooth Address:

identifier.value=formatted as above
identifier.system="urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680"
identifier.assigner.display="EUI-48

Device type

The PHG Device.type is given by the MDC code 531981. The reference identifier for this code is MDC_MOC_VMS_MDS_AHD. "AHD" is the previous name Continua gave to what is now known as the PHG. However, reference identifiers are normative and once accepted, they cannot change. It shall be encoded as follows:

Device.type.coding.code="531981"
Device.type.coding.system="urn.iso.std.iso:11073:10101"
Device.type.coding.display="MDC_MOC_VMS_MDS_AHD: Continua Personal Health Gateway"

Here the display element is optional but highly recommended.

Time synchronization

The time synchronization is mapped as follows:

Device.property.type.coding.code="68220"
Device.property.type.coding.system="urn.iso.std.iso:11073:10101"
Device.property.type.coding.display="MDC_TIME_SYNC_PROTOCOL" (optional)
Device.property.valueCode.coding.code="32-bit code for sync method"
Device.property.valueCode.coding.system="urn.iso.std.iso:11073:10101"
Device.property.valueCode.coding.display="the ref id" (optional)

The 32-bit code for the time synchonization method is given by one of the following values:

32-bit code	Reference identifier	description	partition:term code
532224	MDC_TIME_SYNC_NONE	An uncalibrated and unsynchronized local clock source	8::7936
532234	MDC_TIME_SYNC_EBWW	A manually set time, by ‘eyeball and wristwatch’	8::7946
532225	MDC_TIME_SYNC_NTPV3	Network Time Protocol Version 3.0 (RFC 1305)	8::7937
532226	MDC_TIME_SYNC_NTPV4	Network Time Protocol Version 4.0 (under dev)	8::7938
532227	MDC_TIME_SYNC_SNTPV4	Simple Network Time Protocol v4 (RFC 2030)	8::7939
532228	MDC_TIME_SYNC_SNTPV4330	Simple Network Time Protocol v4 (RFC 4330)	8::7940
532229	MDC_TIME_SYNC_BTV1	Bluetooth Medical Device Profile	8::7941
532235	MDC_TIME_SYNC_USB_SOF	Synced to the 1kHz USB "start-of-frame" clock	8::7947
532230	MDC_TIME_SYNC_RADIO	Atomic Clock synchronization through RF	8::7942
532231	MDC_TIME_SYNC_HL7_NCK	Synchronized via Health Level 7 NCK (network clock)	8::7943
532232	MDC_TIME_SYNC_CDMA CDMA	mobile telecommunications synchronization	8::7944
532233	MDC_TIME_SYNC_GSM	GSM - Network Identity and Time Zone (NITZ)	8::7945

Remaining Optional Data

The treatment of fields that would be in mock System-Model, Production-Specification, Reg-Cert-Data-List, and Mds-Time-Info attributes is the same as in the Phd Device Profile. However, there is an extra set of information in the mock Reg-Cert-Data-List regarding the certified Health & Fitness Service (H&FS) interfaces. A PHG has both PAN and H&FS interfaces.

Display elements are always optional.

If these fields are encoded they shall be encoded as follows:

Specializations

The specializations supported by the PHG may be reported. If reported, they shall be reported in the Device.specializations element for each specialization as follows:

specialization.systemType.coding.code="32-bit specialization code"
specialization.systemType.coding.system="urn.iso.std.iso:11073:10101"
specialization.systemType.coding.display"reference-id plus additional text"
specialization.version="specialization version"

If the PHG supports multiple versions of the specialization and the uploader wants to report this information, additional specializations entries for the additional versions are made. Alternatively the uploader can leave the version field empty.

A PHG is often designed to support all current and future PHDs that support a given version of the 11073-20601 standard. Instead of listing all the specializations individually (which could greatly increase the size of the message) one can use the 'generic' device code. In this case, the specialization.version element, if populated, indicates the version of the 20601 standard. If multiple versions of the 20601 standard are supported and the uploader wants to report this information, a separate 'generic' entries for each version are reported. Alternatively, the version element can be left empty.

An example of generic code use would be as follows

specialization.systemType.coding.code="528385"
specialization.systemType.coding.system="urn.iso.std.iso:11073:10101"
specialization.systemType.coding.display"MDC_DEV_SPEC_PROFILE_GENERIC: supports all 20601 devices"
specialization.version="2"

The following table gives a list of the more common specialization codes:

Specialization	MDC Code partition:term code	Reference Identifier
Generic 20601	8:4169	MDC_DEV_SPEC_PROFILE_GENERIC
Pulse Oximeter	8::4100	MDC_DEV_SPEC_PROFILE_PULS_OXIM
Electro cardiograph	8::4102	MDC_DEV_SPEC_PROFILE_MIN_ECG
Blood Pressure Cuff	8::4103	MDC_DEV_SPEC_PROFILE_BP
Thermometer	8::4104	MDC_DEV_SPEC_PROFILE_TEMP
Respiration rate	8::4109	MDC_DEV_SPEC_PROFILE_RESP_RATE
Weight Scale	8::4111	MDC_DEV_SPEC_PROFILE_SCALE
Glucose Monitor	8::4113	MDC_DEV_SPEC_PROFILE_GLUCOSE
Coagulation meter	8::4114	MDC_DEV_SPEC_PROFILE_COAG
Insulin Pump	8::4115	MDC_DEV_SPEC_PROFILE_INSULIN_PUMP
Body Composition Analyizer	8::4116	MDC_DEV_SPEC_PROFILE_BCA
Peak Flow meter	8::4117	MDC_DEV_SPEC_PROFILE_PEAK_FLOW
Sleep Apnea Breathing Equipment	8::4120	MDC_DEV_SPEC_PROFILE_SABTE
Continuous Glucose Monitor	8::4121	MDC_DEV_SPEC_PROFILE_CGM
Cardiovascular Device	8::4137	MDC_DEV_SPEC_PROFILE_HF_CARDIO
Strength Equipment	8::4138	MDC_DEV_SPEC_PROFILE_HF_STRENGTH
Independent Activity/Living Hub	8::4167	MDC_DEV_SPEC_PROFILE_AI_ACTIVITY_HUB
Medication Monitor	8::4168	MDC_DEV_SPEC_PROFILE_AI_MED_MINDER

In some sense, reporting specialization information about a PHG is superfluous as clearly, if the PHG uploads data from a given device, it supports that device.

PHG Product Information

The table blow provides codes and reference identifiers used in mapping the product information:

11073 Attribute	description	MDC code	MDC reference identifier
System-Model	Model number	531969	MDC_ID_MODEL_NUMBER
System-Model	Manufacturer name	531970	MDC_ID_MODEL_MANUFACTURER
Production-Specification	Unspecified	531971	MDC_ID_PROD_SPEC_UNSPECIFIED
Production-Specification	Serial number	531972	MDC_ID_PROD_SPEC_SERIAL
Production-Specification	Part number	531973	MDC_ID_PROD_SPEC_PART
Production-Specification	Hardware revision	531974	MDC_ID_PROD_SPEC_HW
Production-Specification	Software revision	531975	MDC_ID_PROD_SPEC_SW
Production-Specification	Firmware revision	531976	MDC_ID_PROD_SPEC_FW
Production-Specification	Protocol revision	531977	MDC_ID_PROD_SPEC_PROTOCOL
Production-Specification	Global Medical Device Nomenclature (GMDN)	531978	MDC_ID_PROD_SPEC_GMDN
Reg-Cert-Data-List	Continua version	532352	MDC_REG_CERT_DATA_CONTINUA_VERSION
Reg-Cert-Data-List	Continua Certified Device List	532353	MDC_REG_CERT_DATA_CONTINUA_CERT_DEV_LIST
Reg-Cert-Data-List	Regulation status	532354	MDC_REG_CERT_DATA_CONTINUA_REG_STATUS
PHG only	Continua Certified H&FS List	532355	MDC_REG_CERT_DATA_CONTINUA_AHD_CERT_LIST
Mds-Time-Info	Synchronization method	68220	MDC_TIME_SYNC_PROTOCOL
Mds-Time-Info	Time capabilities	68219	MDC_TIME_CAP_STATE
Mds-Time-Info	High resolution relative time resolution	68224	MDC_TIME_RES_REL_HI_RES
Mds-Time-Info	Relative time resolution	68223	MDC_TIME_RES_REL
Mds-Time-Info	Absolute Time time resolution	68222	MDC_TIME_RES_ABS
Mds-Time-Info	Base offset time resolution	68226	MDC_TIME_RES_BO
Mds-Time-Info	Time synchronization accuracy	68221	MDC_TIME_SYNC_ACCURACY

Primitives

manufacturer="PHG manufacturer"
modelNumber="PHG model number"
serialNumber="serial number"
partNumber="part number"

Hardware, Software, Firmware, Protocol, and Continua Versions

hardware
version.type.coding.code="531974"
version.type.coding.system="urn.iso.std.iso:11073:10101"
version.type.coding.display="MDC_ID_PROD_SPEC_HW + optional text"
version.value="hardware-version"
software
version.type.coding.code="531975"
version.type.coding.system="urn.iso.std.iso:11073:10101"
version.type.coding.display="MDC_ID_PROD_SPEC_SW + optional text"
version.value="software-version"
firmware
version.type.coding.code="531976"
version.type.coding.system="urn.iso.std.iso:11073:10101"
version.type.coding.display="MDC_ID_PROD_SPEC_FW + optional text"
version.value="firmware-version"
protocol
version.type.coding.code="531977"
version.type.coding.system="urn.iso.std.iso:11073:10101"
version.type.coding.display="MDC_ID_PROD_SPEC_PROTOCOL + optional text"
version.value="protocol-version" (Not 11073-20601 protocol!)
Continua
version.type.coding.code="532352"
version.type.coding.system="urn.iso.std.iso:11073:10101"
version.type.coding.display="MDC_REG_CERT_DATA_CONTINUA_VERSION + optional text"
version.value="Continua Version"

The Continua version has a major and minor component separated by a dot (.). For example, "6.1" where "6" is the major version and "1" is the minor version.

Continua Certified PAN interfaces

The Continua certified PAN (Personal Area Network) interfaces are represented as a list of Continua-specified 'PAN' codes. Note there is a difference between certified PAN interfaces and supported PAN interfaces. The Continua-specified certification codes are a combination of a transport 'Tcode' and a specialization code which is based on the 16-bit term code of the MDC code for the specialization. The PAN code is generated by

PANCode = Tcode * 8192 + (specialization term code - 4096)

The transport 'Tcodes' are as follows:

Tcode	Transport
0	Continua version 1.0
1	USB
2	Bluetooth HDP
3	ZigBee
4	Bluetooth Low Energy
5	NFC

The special Tcode of 0 is for Continua version 1.0 when there was no transport component in the reported certified PAN interface codes.

The PANCodes are mapped to a list of property.valueCode elements. The property.type element, which identifies the property, is given by the MDC 32-bit code 532353. Its reference id is MDC_REG_CERT_DATA_CONTINUA_CERT_DEV_LIST.

property.type.coding.code="532353"
property.type.coding.system="urn.iso.std.iso:11073:10101"
property.type.coding.display="MDC_REG_CERT_DATA_CONTINUA_CERT_DEV_LIST + text"
property.valueCodeN.coding.code="PANCodeN"
property.valueCodeN.coding.system="placeholder/fhir/reg-cert-codes "

Note that the property.valueCode element is an array and one can have many of these in a single property element.

Continua Certified Health & Fitness interfaces

The Continua certified Health and Fitness interfaces are represented as a list of Continua-specified 'H&FS' codes as follows:

Health & Fitness Interface	H&FS code	Reference name
PCD-01 web services	0	observation-upload-soap
Consent enabled PCD-01 web service	1	consent-enabled-soap
Capability exchange	2	capabilities
PCD-01 upload using hData	3	observation-upload-hdata
Consent enabled PCD-01 using hData	4	consent-enabled-hdata
Questionnaire CDA	5	questionnaire
Authenticated Persistent Sessions	6	aps
FHIR resource upload	7	observation-upload-fhir

The Health and Fitness codes are mapped to a list of property.valueCode elements. The property.type element, which identifies the property, is given by the MDC 32-bit code 532355. Its reference id is MDC_REG_CERT_DATA_CONTINUA_CERT_DEV_LIST.

property.type.coding.code="532355"
property.type.coding.system="urn.iso.std.iso:11073:10101"
property.type.coding.display="MDC_REG_CERT_DATA_CONTINUA_AHD_CERT_DEV_LIST + text"
property.valueCodeN.coding.code="H&FSCodeN"
property.valueCodeN.coding.system="placeholder/fhir/reg-cert-wan-codes "

Regulation Status

The PHG regulation status is reported as follows:

property.type.coding.code="532354.0"
property.type.coding.system="placeholder/fhir/IEEE.ASN1"
property.type.coding.display="regulation-status"
property.valueCode.coding.code="Y/N"
property.valueCode.coding.system="http://hl7.org/fhir/v2/0136 "
property.valueCode.coding.display="Y=unregulated N=regulated"

Time Synchronization Accuracy

The time synchronization accuracy is reported in microseconds as follows:

Device.property.type.coding.code="68221"
Device.property.type.coding.system="urn.iso.std.iso:11073:10101"
Device.property.type.coding.display="MDC_TIME_SYNC_ACCURACY" (optional)
Device.property.valueQuantity.value="time-sync-accuracy"
Device.property.valueQuantity.system="http://unitsofmeasure.org"
Device.property.valueQuantity.code="us" (UCUM code for microseconds)

Phg Device JSON Example

The following is an example of a Phg Device resource.

{
	"resourceType": "Device",
	"id": "SysId-ecde3d4e58532d31",
	"identifier": [{
		"system": "urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680",
		"value": "ec-de-3d-4e-58-53-2d-31",
		"assigner": {
			"display": "EUI-64"
		}
	}],
	"manufacturer": "Continua Medical PHGs",
	"type": {
		"coding": [{
			"system": "urn:iso:std:iso:11073:10101",
			"code": "531981",
			"display": "MDC_MOC_VMS_MDS_AHD"
		}]
	},
	"specialization": [{
		"systemType": {
			"coding": [{
				"system": "urn:iso:std:iso:11073:10101",
				"code": "528457",
				"display": "MDC_DEV_SPEC_PROFILE_GENERIC: Handles all 20601 compliant devices"
			}]
		},
		"version": "2"
	}],
	"version": [{
			"type": {
				"coding": [{
					"system": "urn:iso:std:iso:11073:10101",
					"code": "531975",
					"display": "MDC_ID_PROD_SPEC_SW: Software revision"
				}]
			},
			"value": "1.0.0"
		},
		{
			"type": {
				"coding": [{
					"system": "urn:iso:std:iso:11073:10101",
					"code": "532352",
					"display": "MDC_REG_CERT_DATA_CONTINUA_VERSION: Continua version"
				}]
			},
			"value": "6.0"
		}
	],
	"property": [{
			"type": {
				"coding": [{
					"system": "urn:iso:std:iso:11073:10101",
					"code": "68220",
					"display": "MDC_TIME_SYNC_PROTOCOL: Time synchronization protocol"
				}]
			},
			"valueCode": [{
				"coding": [{
					"system": "urn:iso:std:iso:11073:10101",
					"code": "532233",
					"display": "MDC_TIME_SYNC_GSM: "
				}]
			}]
		},
		{
			"type": {
				"coding": [{
					"system": "urn:iso:std:iso:11073:10101",
					"code": "532353",
					"display": "MDC_REG_CERT_DATA_CONTINUA_CERT_DEV_LIST: certified device list as transport-specialization combo"
				}]
			},
			"valueCode": [{
				"coding": [{
					"system": "http://pcha.org/phd/documents/reg-cert-codes",
					"code": "4"
				}]
			}]
		},
		{
			"type": {
				"coding": [{
					"system": "urn:iso:std:iso:11073:10101",
					"code": "532355",
					"display": "MDC_REG_CERT_DATA_CONTINUA_AHD_CERT_LIST: certified Upload classes"
				}]
			},
			"valueCode": [{
					"coding": [{
						"system": "http://pcha.org/phd/documents/reg-cert-wan-codes",
						"code": "2"
					}]
				},
				{
					"coding": [{
						"system": "http://pcha.org/phd/documents/reg-cert-wan-codes",
						"code": "7"
					}]
				}
			]
		},
		{
			"type": {
				"coding": [{
					"system": "http://hl7.org/fhir/IEEE.ASN1",
					"code": "532354.0",
					"display": "regulation-status"
				}]
			},
			"valueCode": [{
				"coding": [{
					"system": "http://hl7.org/fhir/v2/0136",
					"code": "Y",
					"display": "Device is not regulated"
				}]
			}]
		}
	]
}