EIT Health & IN-4-AHA roundtable

On the 24^th of November 2021, EIT Health Scandinavia organized a roundtable within the IN-4-AHA project to discuss insights related to the German Digital Health Care Act and shed light on the status of digital health applications at national and European level. In particular, the aim was to answer the question of whether this German model could be suitable for other European countries as well.

To this end, 15 stakeholders from the Nordic countries (incl. Estonia) were invited to share their views. This resulted in a diverse panel filled with decision makers and opinion leaders such as regulatory authorities, health insurance providers, healthcare experts, service providers, and developers. They were accompanied by a virtual audience of 30 listeners from all over Europe.

The event consisted of two sessions. Kicking off the first session, Erik Forsberg, previous Managing Director of EIT Health Scandinavia, presented lessons from previous roundtables on accelerating healthcare innovation in the Nordics. Then, Henrik Matthies, Managing Director at the Federal Ministry of Health and Health Innovation Hub in Germany, shared the German experiences with DiGA. Tim Andrews, Co-Founder and COO at ORCHA, contributed the UK perspective on bringing digital health applications to market. Lastly, Anders Tunold-Hansen from the Nordic Interoperability Project provided an overview of achievements under the Nordic cross-border N!P project.

But what do we actually refer to when we speak of DiGA/DiGAs? The German Federal Institute for Drugs and Medical Devices (BfArM) summarized six characteristics a medical device should fulfil to be called a DiGA:

• Medical device of risk class I or IIa (according to MDR or under transitional provisions according to MDD)
• The main function of the device is based on digital technologies
• The device is not an application that merely serves to read or control a device; the medical purpose must be substantially achieved by the main digital function
• The device supports detection, monitoring, treatment, or mitigation of disease or the detection, treatment, mitigation, or compensation of injury or disability
• The device is not for primary prevention
• The device is shared by the patient or healthcare provider and patient, i.e. applications that are only used by a physician to treat patients (office equipment) are not DiGAs.

The second session consisted of the roundtable discussion with stakeholders, centered around nine related questions:

1. What are the main challenges in bringing digital health devices to the market?
2. Does the current reimbursement system cover the patient’s expenses in your country?
3. Is your country ready to accept digital health devices that have been accepted for reimbursement in other EU countries?
4. What have been the main challenges in adopting and implementing the new regulations, and who are the most active stakeholders in driving development going forward?
5. Do you believe that the DiGA regulation from Germany could be a basis for developing regulations in your country?
6. Do you think we need to harmonize the digital health device market regulation, and if so, what are the next steps?
7. If you are looking at the best practices of the digital health devices in your country, which of these practices could be used by other countries in the Nordic Region, or across Europe?
8. What parts should be developed together and what should be developed in the individual countries?
9. What do you see as the three main challenges in bringing digital health devices to the market?

Access the official event report via the button below and learn more about the outcomes of the discussion of each question.