What is DiGA?
"Digital health applications (DiGA – in German: “Digitale Gesundheitsanwendungen”) open up a wide range of possibilities, both regarding the diagnosis and treatment of diseases as well as supporting a self-determined, healthy lifestyle. Thus, we can consider DiGA to be "digital assistants" in the hands of the patient." They are supposed to be digital Applications that come under Medical device risk class I or IIA of MDR. For more details refer BfArM.
History on DIGA
On December 19th 2019 the Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) came into effect, introducing the “app on prescription” as part of healthcare for patients. This means that around 73 million insured in the statutory health insurance(SHI, German: Gesetzliche Krankenversicherung, GKV) can now access digital health applications (Digitale Gesundheitsanwendungen, DiGA) through a doctor's or psychotherapist’s prescription. Furthermore, if they can provide their SHI funds with proof of a corresponding indication, they are also eligible to receive such an app without needing a prescription.
It is introduced and managed by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), which is an independent federal higher authority under the Federal Ministry of Health.
Market Favoring Points
I would like to start with the phrase "Necessity is the mother of all inventions". If you look at the German market in detail, you will see that there are some serious gaps, particularly in terms of medical professionals available compared to the number of patients. The number of people looking for psychotherapy in Germany rose by 40%, and a majority had to wait over six months for treatment, according to the RBB(Berlin broadcaster).
As part of COVID, the healthcare system in Germany was load tested, which again revealed gaps in the entire healthcare system.
Germany is an advanced economy with an aging population. At the end of 2014, 81.2 million people called it home - 22.2 million of whom were over 60 – more than one in four (27%). One-fifth (21%) were even 65 and over, with 11% having celebrated their 75th birthday or more. This increased demand for healthcare has led to digital solutions breaking into the market as an alternative. Going forward, this number is going to increase further.
The combination of these problems makes this market ideal for digital health applications.
Businesses cannot thrive without the opportunity to earn money. And interestingly, the global digital therapeutic market is estimated at 4.5 billion USD in 2022, and projected to reach 17.7 billion USD by 2027 with a CAGR of 31.6%(Reference)
What Benefits Does DiGA Application Offer Us
The DiGA directory provides comprehensive information about the qualities and services of the devices so that insured persons, physicians, psychotherapists, and health insurance companies can make well-informed decisions. In our one word "empower stakeholders".
As Manufacturer
Maximum transparency is a key focus: The path to reimbursable is meant to be predictable for the manufacturers through the formulation of unambiguous requirements and interpretation aids.
Insurance will pay the manufacturer for every therapy performed using their solution.
As Physician
Once the #diga is listed in the directory, physicians receive an additional reimbursement, in case additional medical services are necessary as part of the treatment. Additional therapies to take care of the patient.
As Patient
Awareness and detailed information along with faster care through digital means.
Challenges Associated with DiGA Applications
As Manufacturer
There are many risks with make DiGA application development bitter for many manufacturers.
If the manufacturer and insurance do not come to an agreement on the price, BfArM can step in as arbiter. In this case, the manufacturer may have delays or fewer bargain options.
With the number of digital applications currently available in DiGA certain therapies. This has led to a robust competitive climate; many sectors are oversaturated, leaving little room for future growth.
Effective use of Digital Therapeutics (DTx) also poses a challenge.
Manufacturers must incur substantial expenses if they wish to develop and be part of DiGA.
Physician
As a physician, it may be difficult to choose the right app since the awareness and effectiveness of each application will be limited.
Insurance
Disputes with the manufacturer over the cost of digital application. And deriving a cost justifiable by the service it provides is a tough challenge.
Regulators
Not getting enough participation from manufacturers in some of the complex areas where regulatory challenges are higher.
The process of Building a Qualified DiGA Digital Application
To introduce new applications into DiGA there are a few prerequisites to follow, and there are procedures designed to speed up the process. Within three months from the start of filing to completion of the application. As part of the DiGA assessment, BfArm needs to evaluate and categorize the results:-
Approved
Denied
Provisional Listing
Within three months, these conclusions must be drawn.
Several mandatory recommendations must be followed to get approval for the solution. Below are BfArM's evaluation criteria applicable to the manufacturer.
Needs to provide evidence of the Quality.
Specific evaluations are done on Data protection, data security measures of the application and organization.
User Friendliness of the application is evaluated.
Interoperability along with safe and patient-focused interaction with the electronic health insurance card (Elektronische Gesundheitskarte, eGK), the electronic personal health record (Elektronische Patientenakte, ePA)
Evidence of the positive healthcare effect of the DiGA provided by the manufacturer
Even, If the manufacturer cannot provide sufficient evidence for a positive healthcare effect but all other requirements are fulfilled, it will be possible to apply for a provisional listing in the directory. In this case, the required comparative study can be conducted within the trial phase of one year, or in exceptions of up to two years.
Good Manufacturing Practices Essential for DiGA Applications
For simplicity of this article, I am capturing only a few of the many technical/function/operational good practices to reduce development costs and accelerate application approval.
Follow the Quality Management System(QMS) as per #iso13485 in your organization-wide process.
A key success factor is to manage software lifecycles according to #iec62304.
Perform TUV technical and organizational audits and measures according to EU-DSGVO
Interoperability to Telematic Infrastructure(TI)
DiGA Defined Areas of Acceptance and Available DiGA Manufacturers
DiGA does not define any specific area of care but defines guidelines for the same. Manufacturers need to derive their DTx and provide solutions.
DiGA is an inviting digital application on various therapies which are grouped as below:-
Respiratory tract
Kaia Health Kaia COPD is a digital application for adult patients with COPD
Genitals, Kidney, and urinary tract
Endo Health GmbH digital medical product for multimodal support for people affected by endometriosis.
Heart and circulation
ProCarement GmbH therapy companion for patients with heart failure.
Hormones and metabolism
aidhere Provides application that helps patients to reduce their weight in the long term by changing their habits in the areas of exercise, nutrition and other behavior.
Cancer
#gaia Application for breast cancer patients who have completed their initial treatment, feel stressed
PINK gegen Brustkrebs GmbH provides a digital application that serves to improve the health-related quality of life and health literacy as well as alleviate the psychological, psychosomatic, and somatic consequences of breast cancer.
Muscles, bones, and Joints
PrehApp GmbH * We are hiring * GmbH digital health application for patients aged 14-65 with anterior knee pain.Mawendo GmbH provides training programs with exercise videos, health information, and documentation options.
Nervous Systems
Perfood Their application represents guideline-based prophylaxis of migraine attacks.
Ears
Sonormed GmbH provides a solution for digital tinnitus counseling for tinnitus patients as first aid.
Psyche
Close to 50% of the applications are built for the psyche. Interestingly DiGA manufacturers see a lot of potential as well as tight competition in this area.
HelloBetter A Mental Application Building Organization Based in Deutschland, provides multiple applications for psychotherapy.
Other
neolexon Aphasia offers people with aphasia and/or speech apraxia speech therapy training for daily practice at home as a supplement to speech therapy.
Digestion
Cara by HiDoc Technologies Cara Care for irritable bowel syndrome is a digital health application for the treatment of irritable bowel syndrome.
Take Away
Digital applications were once confined to merely storing and viewing data, but the German government has taken a proactive approach to regulating the digital health market. Their example provides a valuable lesson to many other governments worldwide. Investment in Digital Therapeutics Apps solely for the visibility of DiGA may not bring great financial gains, however, being part of DiGA can be used as a marketing tool to tap into specific segments of the therapeutics application market. This is a new initiative that is still in the initial phases of growth, as we can see around 50+ applications already listed.
To understand more and view all the applications available in DiGA, visit DIGA.
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