Following the Digital Healthcare Act (in German, DGV), promulgated on December 19, 2019, 73 million insured in the German Statutory Health Insurance can access public healthcare by means of digital health applications (in German, DiGA).
The costs associated with the use of such applications will be reimbursed by Statutory Health Insurance companies, provided that the application:
- Falls within the definition of DiGA given by the German legislation;
- Passes the assessment of the Federal Institute for Drugs and Medical Devices (in German, BfArM);
- Is used either in accordance with the prescription of a physician/psychotherapist or with the approval of the health insurance company*.
*These conditions are cumulative.
What is DiGA – Digital health application?
According to Section 33a of the Social Code Book in order to be considered as a DiGA, an application should have the following characteristics:
1. Low-risk medical device.
The application should be a CE-marked medical device of the risk class I or IIa, according to the classification rules outlined in the Medical Device Regulation 2017/745 (MDR)or, in case of legacy devices, in the Medical Device Directive 93/42/EEC (MDD);
2. Used as a support to the recognition, monitoring, treatment or alleviation of disease or the recognition, treatment or alleviation or compensation of injuries or disabilities.
While these purposes largely reflect those listed in Art. 2(1) MDR (definition of medical device), there is no perfect correspondence. The prevention of a disease, for example, is not included in Section 33a. Consequently, applications meant to promote a healthy lifestyle or to prevent the insurgence of a pathology will not be considered as DiGA;
3. Its main function should be based on digital technologies.
While it is possible for the DiGA to collect the necessary data via sensors or wearables, its medical purpose (e.g. recognition of a disease) must be achieved by means of its digital functions. In other words, the collected data will have to be analyzed and processed by the algorithms of the app according to its specific medical purpose (e.g. proposing a diagnose or suggesting a treatment);
4. Its main function should not merely consist in the collection of data;
Following what mentioned above, it will not be sufficient for the app to present the collected data to the user. The app will have to elaborate the data to extract new original information (e.g. treatment suggestion). This mirrors the case of Snitem and Philips France, where the Court of Justice of the EU (2017) declared that ‘’software that cross-references patient-specific data with the drugs that the doctor is contemplating prescribing, and is thus able to provide the doctor, in an automated manner, with an analysis intended to detect, in particular, possible contraindications, drug interactions and excessive dosages, is used for the purpose of prevention, monitoring, treatment or alleviation of a disease, and therefore pursues a specifically medical objective, making it a medical device within the meaning of Article 1(2)(a) of Directive 93/42. That is not the case, however ,for software that, while intended for use in a medical context, has the sole purpose of archiving, collecting and transmitting data, like patient medical data storage software, the function of which is limited to indicating to the doctor providing treatment the name of the generic drug associated with the one he plans to prescribe, or software intended to indicate the contraindications mentioned by the manufacturer of that drug in its instructions for use”.
5. It should be used autonomously by the patient or by the patient together with the healthcare professional.
In this regard, it is essential that the patient interacts with the application. An application used exclusively by the healthcare professional (physician or psychotherapist) would not be considered as a DiGA;
When is a DiGA reimbursed?
To be covered by the Statutory Health Insurance, a DiGA must pass the quality assessment conducted by the BfArM. Such a procedure, structured as 3 months “fast track”, is divided into two parts:
1. The first part of the assessment is intended to verify whether the application satisfies safety, suitability for use, data protection, information security and quality requirements.
- With regards to safety and suitability for use, the BfArM only checks the formal legality of the CE marking, as these requirements are assumed to be fulfilled by the presence of the manufacturer’s Declaration of Conformity, and (in case of class IIa software) of the CE certificate issued by a Notified Body;
- A more thorough assessment will focus on the respect of data protection and information securityprinciples. Manufacturers must ensure compliance with the provisions of the EU General Data Protection Regulation, in particular Art.9, and with those of the German Federal Data Protection Act (BDSG). The framework of the applicable legislation is then complemented by the specific provisions set out by the Digital Health Applications Ordinance (DiGAV), in relation to data protection and information security;
- Vis-à-vis quality, special attention is given to the interoperability of the application, as the legislator aims at facilitating the integration of DiGAs into the existing German e-health infrastructure.
2. The second part of the assessment revolves around the evidence of positive healthcare effects of the DiGA.
Manufacturers must demonstrate that the use of their applications generates either:
a. medical benefits to the patient, intended as:
· “an improvement of the patient’s state of health or quality of life, the reduction of the duration of a disease or the prolongation of survival” (Federal Institute for Drugs and Medical Devices, 2020, p.77-78).
b. patient-relevant improvements in the structure and/or processes of the healthcare system.
DiGA Directory
If the assessment procedure has a positive outcome, the DiGA is approved and added to the DiGA Directory, the official BfArM’s database containing comprehensive information for both patients and practitioners with regards to the approved applications.
The listing in DiGA Directory ensures the reimbursement of the application, provided that its use has been prescribed by a practitioner or approved by the insurance company.
In case the manufacturer is unable to provide sufficient evidence of the application’s positive healthcare effects, the DiGA will be temporarily approved and added to the DiGA Directory for 12 months, if after this period, the manufacturer is still unable to provide the required evidence, the application will be removed from the Directory, and therefore excluded from the reimbursement.
Conclusion
While it is still early to evaluate the long-term effects of this new ordinance, as it has been implemented only recently, both patients and manufacturer are likely to benefit from it.
On the one hand, these provisions might facilitate access to public healthcare for more than 70 million people. Considering that the current pandemic has imposed heavy restrictions on people movement and caused countless delays to non-essential medical services, the possibility to access public healthcare from one’s living room is more convenient than ever.
On the other hand, the new ordinance is likely to boost the request for digital health applications, thus attracting a great number of manufacturers to the German market. For Non-EU manufacturers interested in applying to the DiGA Directory, the first step will be designating a European Authorized Representativeand ensuring that their devices comply with the EU Medical Legislation.
Tommaso POLES
Regulatory Affairs Department
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References:
- Federal Institute for Drugs and Medical Devices (BfArM). (2020). The Fast-Track Process for Digital Health Applications (DiGA) according to Section 139e SGB V. Retrieved on 23/12/2020 from https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.pdf;jsessionid=7CA18B83B4E38148C99503C1140D262B.2_cid344?__blob=publicationFile&v=2
- Court of Justice of the European Union. (07/12/2017). Judgment of the court of 7 December 2017. C-329/16, ECLI:EU:C:2017:947. Retrieved on 23/12/2020 from http://curia.europa.eu/juris/document/document.jsf?text=&docid=197527&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=312121