This profile defines a Personal Health Device within the context of § 374a SGB V. A Personal Health Device acc. to this profile is any medical aid or implant that

• is distributed to patients at the expense of the statutory health insurance and
• transmits the data about the patient electronically to the device manufacturer or third parties, which make the data available to patients and/or physicians via publicly accessible networks.

Personal Health Devices that fulfill the criteria of this regulation MUST be able to pass on data to authorized Digital Health Applications (DiGA acc. § 374a SGB V) using the protocols and interfaces as defined in the HDDT specification.

This profile helps a device data consuming DiGA to

• increase patient safety by comparing the serial number of a Personal Health Device as presented with this profile with the serial number the patient may have provided to the DiGA
• increase data quality by getting information about the current status of the end-to-end communication flow from the Personal Health Device to the device backend and thus being able to detect if there may be more data available for the requested period
• optimize its interactions with the device data providing resource server by getting access to the DeviceDefinition resource that holds static attributes about the device and its connected backend (e.g. minimum delay between data measurement and data availability)

Obligations and Conventions:

The Personal Health Device's backend regularely synchronizes with the device hardware through a gateway (Personal Health Gateway). The minimum delay that the concrete end-to-end synchronization from the Personal Health Device to the device backend imposes is provided by the BfArM HIIS-VZ (Device Registry) through the static attribute Delay-From-Real-Time. If a resource server has not synchronized with the connected Personal Health Device for a time span longer than Delay-From-Real-Time(e.g. due to temporarely lost Bluetooth or internet connectivity), the status of the Device resource that represents the Personal Health Device MUST be set to unknown.

Constraints applied:

• status is set to Must Support in order to allow a DiGA to detect missing data (e.g. due to connection issues)
• deviceName and serialNumber are set to Must Support to allow a validation of the source of device data by comparing this information with information printed on the Personal Health Device
• definition is constrained as a mandatory element in order to enable a DiGA to obtain static device attributes through this reference
• expirationDate is set to Must Support to allow a DiGA to be aware of regular sensor changes (e.g. for patient wearing a rtCGM)