Regularly reaching for or glancing at a smartphone shows that almost nothing works without digital apps anymore. And this doesn’t just affect young people. The current tense situation due to the pandemic situation brings out the advantages of digital innovation in the medical field. A visit to the doctor is unnecessary because you can talk to the medical professional via smartphone or PC; health apps on the smartphone collect health-related data, evaluate it and forward it to the doctor for further treatment. The digital devices are motivators, evaluators and informers all in one. They do not replace communication between patients and doctors, but they facilitate it, save time, travel and costs – in short, the digital transformation in medicine can no longer be stopped.
Soon, even doctors will be able to prescribe apps on prescription, and the costs will then be covered by health insurers.

To strengthen digitization in medicine, the German government has introduced a number of new legal regulations:

Act for Better Care through Digitization and Innovation.

(Digital Care Act – DVG) came into force on December 19, 2019.

The Digital Supply Act in the Federal Law Gazette

Ordinance on the procedure and requirements for reviewing the eligibility for reimbursement of digital health applications in the statutory health insurance system

(Digital Health Applications Ordinance – DiGAV).

Digital Health Applications Ordinance (DiGAV) in the Federal Law Gazette

What changes do the DVG and DiGAV bring for medical device manufacturers?

Insured persons will receive a benefit claim for Digital Health Applications (DiGA). A new procedure will be established at the BfArM, in which the BfArM will test the respective DiGA for safety, functional suitability, quality, data security and data protection. Subsequently, the DiGA is provisionally placed online for one year in a corresponding directory, and can then be prescribed by physicians and reimbursed by the statutory health insurance. The manufacturer has one year to demonstrate that the DiGA improves patient care. This will enable patients to use the health apps/-DiGA more quickly and with less bureaucracy.

In the future, health insurance companies will be able to promote the development of digital innovations in a needs-based and patient-oriented manner and use up to two percent of their financial reserves for this purpose as part of the acquisition of investment assets, e.g., through the targeted promotion of an idea or through participation in health-innovative capital funds. The innovation fund available at will be continued and further developed.

The health insurance funds are allowed to inform insureds who so desire about innovative care offerings.

IT security among physicians in private practice will be strengthened. Certified service providers can support practices in implementing IT security standards.

Networking of the healthcare system: In the future, information exchange between the insured and various healthcare providers will be easier, faster and based on international standards.

The DiGAV will ensure that high-quality DiGAs reach care quickly and thus generate added value for the insured.

The BfArM has developed a fast-track procedure for digital health applications (DiGA) in accordance with Section 139e of the German Social Code, Book V, which is intended to serve as a guide for manufacturers, service providers and users.
The milestones for the implementation of the fast-track procedure are as follows.
(Source BfArM).

Which medical digital applications count as DiGA?

A DiGA is a medical device in risk class I or IIa (according to MDR or, under transitional provisions, MDD) that has the following characteristics:

Digital technologies are the primary function of the DiGA.

The DiGA does not serve only to read or control a device; the medical purpose must be substantially achieved by the main digital function.

The DiGA supports the detection, monitoring, treatment, or mitigation of disease or the detection, treatment, mitigation, or compensation for injury or disability.

The DiGA is not used for primary prevention.

DiGA is shared by patients or by the provider and patient.

Applications used only by the physician to treat patients are not a DiGA.

A DiGA can include devices, sensors (and other hardware such as wearables) in addition to software. The main function must remain predominantly digital. The hardware must be necessary for achieving the purpose of the DiGA and must not be a privately financed object of everyday life (e.g., a gym mat for implementing DiGA exercises). However, the DiGA may, for example, obtain data from a smartwatch via a standard interface if it has been considered and positively assessed during the conformity assessment.

The DiGA can also be combined with services that include counseling, coaching, or private medical services. However, these services are not reimbursed by SHI. The positive care effect of a DiGA must be demonstrated without the use of such additional services.

The DiGA manufacturer may offer additional optional services and features (e.g., linkage to a social network, appointment booking, or apps/device connectivity). However, these must not have a medical purpose or influence the medical purpose, must not endanger or change the positive care effects, must be segregated (separate) and must not impair the DiGA even in the event of an error, and must be separately identified. The user is responsible for the extra costs.

Primary prevention digital applications cannot be included in the DiGA directory because primary prevention is directed at the general population and is intended to prevent the development of disease (i.e., for the population that is not [yet] ill). A DiGA that prevents the worsening of a disease state or avoids secondary diseases, on the other hand, is subsumed under the term “treatment” and belongs in the DiGA directory. The prerequisite for this is: there is a risk factor in the sense of a disease that can be coded as a diagnosis.

Who is eligible to apply?

The procedure for the inclusion of a DiGA in the DiGA list of the BfArM is initiated upon application in written or electronic form by the manufacturer of the medical device within the meaning of the applicable medical device regulations or by third parties on behalf of the manufacturer with his power of attorney.

What are the contents of the application?

§ Section 139e (2) sentence 2 of SGB V lists the contents of the application. These include evidence that the DiGA meets the requirements for safety, functional capability and quality of the medical device and for data protection, that data security is ensured according to the state of the art and that it has positive supply effects. In addition, the manufacturer must list many other details listed in Section 2 of the DiGAV and complete and attach Attachments 1 and 2 of the DiGAV to the application.

What are the positive supply effects and how are they demonstrated?

Positive care effects, as defined by the DiGAV, are either.

A medical benefit, with a patient-relevant effect, particularly in terms of improving health status, shortening the duration of illness, prolonging survival, or improving quality of life; or

patient-relevant structural and procedural improvements in care in the context of detecting, monitoring, treating, or mitigating disease, or detecting, treating, mitigating, or compensating for injury or disability, aimed at supporting patients’ health care transactions or integrating processes between patients and providers. In particular, they include the areas of coordination of treatment processes, facilitation of access to care, patient safety, alignment of treatment with guidelines and recognized standards, etc. (§ 8 DiGAV).

The applicant specifies the positive care effect of the DiGA to be demonstrated and the patient group for which the positive care effect is to be demonstrated. The positive supply effect postulated by the DiGA manufacturer must be consistent with the intended purpose as well as with the functions, the contents and the statements published by the manufacturer regarding the DiGA.

The manufacturer shall submit a comparative study, alternatively also prospective comparative study or quantitative comparative studies, to prove the stated positive supply effects (Section 10 DiGAV). The methodological approach chosen must be appropriate to the positive supply effect to be demonstrated.

The manufacturer shall submit a comparative study, alternatively also a prospective comparative study or quantitative comparative studies, to prove the stated positive supply effects (Section 10 DiGAV). The methodological approach chosen must be appropriate to the positive supply effect to be demonstrated.

The retrospective and prospective comparative studies must have been conducted in Germany, registered in a public study registry, and published on the Internet with the full results (including negative results) within twelve months after completion of the study (personal data, trade secrets, etc. may be redacted). Study reports must be prepared in compliance with the relevant, internationally recognized standards for the presentation and reporting of studies.

We show you here how the procedure works. (Source BfArM)

The entire application process for inclusion of a DiGA in the DiGA directory at BfArM is done exclusively via the application portal at BfArM (currently not yet online, but planned for mid-September 2020).

After the BfArm has conducted a formal review of the documents for completeness and, if necessary, additional requirements, the actual review of the application begins. With the start of the processing period, the BfArM has a maximum of three months for the evaluation to notify the applicant by notice whether his or her DiGA will be included in the DiGA list for testing or definitively, or whether the application will be rejected.

If a DiGA is provisionally included in the DiGA Directory, the manufacturer has twelve months (trial period) to demonstrate positive coverage effects. The manufacturer can also extend the trial phase once by up to twelve months.

After the trial phase has expired, the BfArM will issue a decision within three months as to whether the DiGA in question will finally be included in the DiGA list. If the BfArM rejects the inclusion, the DiGA will be removed from the list by the BfArM. The manufacturer may submit a new application at the earliest twelve months after the rejection decision and submit new evidence of positive supply effects. Repeated provisional inclusion in the DiGA list for testing purposes is not permitted.

The manufacturer is obliged to notify the BfArM of any significant changes to the DiGA after it has been included in the list. If there are changes to the information that is publicly available online in the directory, the manufacturer is also required to update it.

Pictorial representation of the process (source BfArM).

What are the costs for applicants?

Details on the fees to be paid can be found in Section 139e of the Fifth Book of the German Social Code (SGB V). In general, these amount to three- to four-digit sums:

Final admission of a DiGA: 3,000 to 9,900 euros.

Final admission of a trialed DiGA: 1,500 to 6,600 euros.

Extension of the trial period by up to twelve months: 1,500 to 4,900 euros.

Cancellation of a DiGA upon request: 200 euros.

Processing of a notification of substantial changes: 1,500 to 4,900 euros.

Modification to the information published in the directory: 300 to 1,000 euros.

Consultation of the DiGA manufacturer: 250 to 5,000 euros (minor in scope general oral, written or electronic information is excluded).

Other changes brought by DGV and DiGAV:

Telematics infrastructure to be expanded. A mandatory digital network for the healthcare sector will be created and a nationwide introduction of the electronic patient record (ePA) will be established. Pharmacies are to be connected to the telematics infrastructure (TI) by the end of September 2020 and hospitals by January 1, 2021 (midwives, physiotherapists, nursing and rehabilitation facilities on a voluntary basis). Physicians who do not want to connect will pay an increased fee deduction of 2.5% as of March 1, 2020.

Video consultation hours become commonplace. Doctors are allowed to provide information about video consultation hours on their website and hold them accordingly.

Administrative processes will be simplified through digitization and will reduce paperwork. In addition to the electronic certificate of incapacity for work and the e-prescription, all other initiated services (e.g., doctor’s letters) can also be prescribed electronically.

To improve knowledge in health research, the billing data available from the health insurance funds will be compiled pseudo-anonymously by the Research Data Center and made available to research in anonymized form. Regulations on data transparency will be further developed.

All insured persons participate in digitization. Health insurers will be required to provide their insureds with offers to promote digital health literacy. If they wish, the insured can learn how to use digital procedures and applications, e.g., by using health apps or the electronic patient card.

Future of the electronic patient card is still uncertain. Much still needs to be adapted in the SGB V in terms of data protection law, and further comprehensive regulations on the patient card need to be defined. There will be a separate law for this.

However, the electronic patient card will still be introduced on January 1, 2021.

Please note that all details and lists do not claim to be complete, are without guarantee and are for information purposes only.