Smoke Free for Digital Health Applications (DiGA), Interoperable Data Export
Introduction
This profile aims to describe the interoperable data export format used by the Smoke Free 23 GmbH (trading as Smoke Free) for its products that are recognized as “Digital Health Applications” (digitale Gesundheitsanwendungen, DiGA) pursuant to German Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG). The DiGA is designed to support the treatment of nicotine addiction as defined by ICD-10 GM Code F17.2 ("Mental and Behavioural Disorders Due to Tobacco Use, Addiction Syndrome"). The DiGA is designed to support the treatment of nicotine addiction as defined by ICD-10 GM Code F17.2 ("Mental and Behavioural Disorders Due to Tobacco Use, Addiction Syndrome").
Background
Digital health applications are subject to various requirements and German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) publishes a guide for manufacturers, service providers and users of such applications to clarify these. According to the DiGA guide published by BfArM, a DiGA shall allow the insured person to export their data collected from the DiGA in two distinct formats for two distinct purposes. One as a human-readable, printable format to allow the user to use it for their own purposes and to share with their physician. The other as a machine-readable, interoperable format that can be processed by other digital applications [1].
For interoperability, an open, internationally recognized profile is recommended until relevant medical information objects (MIOs) are defined by the Federal Association for Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung, KBV), which in the future will be exchangeable via the electronic patient record (elektronische Patientenakte, ePA).
Scope & Disclaimer
This profile details the content of the interoperable data export that is made available in the DiGA Smoke Free. The data export format explained here follows the same basic principles and applies to all present and future DiGA products developed by Smoke Free 23 GmbH.
For interoperable export, Smoke Free 23 GmbH relies on the FHIR® standard published by HL7® [2]. Smoke Free follows the openly published FHIR® Specification v4.0.1: R4 without further profiling and generates a valid JSON file as export. The JavaScript Object Notation (JSON) is a standardized, open, text-based format for displaying structured data. This document does not constitute an implementation guide for FHIR®.
HL7®, FHIR® and the FHIR [FLAME DESIGN]® are the registered trademarks of Health Level Seven International and their use does not constitute endorsement by HL7.
Target Audience
This profile is aimed at the relevant stakeholders (regulators, manufacturers, physicians and patients) in the public health sector to help them understand the format of the data objects used by Smoke Free.
Exporting Data
In the settings page of the DiGA, patients are given the option to export as part of a ZIP file, which contains a human readable PDF, and an interoperable single JSON file.
The JSON file is presented using the FHIR® Bundle resource [3]. A Bundle is a resource that is a self-contained set of resources to act as an exchangeable and persistable collection.
Each bundle contains a data entry structured according to the FHIR® Patient resource [4], and FHIR® Observation resource [5].
Patients are identified by a unique 12-digit alphanumeric code that is generated by the system. This resource also contains information on the nickname and other optional variables the patient has provided during their use of the DiGA.
Observations are made by the user about their progress, these observation entries can be categorized as “missions”, “cravings” or “diaries”. The entries represented as observations differ based on the type. Following the recommendations of the FHIR® standard, and where available valuesets will be coded using Logical Observation Identifiers Names and Codes (LOINC) [6]. Furthermore, when used details regarding the interpretation are similarly provided with appropriate LOINC codes and text descriptions.
Communication & Inquiries
In case of further questions, please feel free to get in touch with us at support@smokefree.de