Communications and Public Affairs Lead, EIT Health Ireland-UK
It is now commonplace to manage healthcare at home with the aid of digital health technologies, many of which provide relief to patients while they await their next in-person appointment.
During Covid-19, 44% of patients used new devices or apps to help manage conditions remotely, according to data gathered by Accenture. This is a habit that has stuck. To aid this trend, an abundance of mobile health applications flooded onto the main app stores — approximately 350,000, according to IQVIA, with 5 million downloads recorded daily.
Amid such a crowded market, we must ask: how safe are these unregulated technologies? And how can patients differentiate high-quality solutions that could make a positive impact on their health from those that don’t?
The first answer to this came in 2019 when Germany passed the Digital Healthcare Act (DGV) and created a dedicated regulatory approval and reimbursement pathway for CE-marked digital health applications.
Under this legislation, clinicians can prescribe an approved digital health solution (locally known as a ‘DiGA’) to patients. Developers of those solutions then get reimbursed by the insurer.
Benefits for users
These health apps or web-based platforms are used to support a patient’s treatment — not replace seeing a doctor. Patients are empowered to take control of their rehabilitation by self-monitoring their recovery and completing a course of therapy at home. This could create greater access to care.
For clinicians, digital therapeutics could bridge the gap while patients await in-person appointments, alleviating pressure on hospital waiting lists. This affords them more time to manage the most complex cases.
Both patients and clinicians gain access to a directory of certified solutions, taking them away from the overwhelming options available on the consumer app stores. They may discover a safe treatment that’s right for them.
These health apps or web-based
platforms are used to support a patient’s
treatment — not replace seeing a doctor.
For the health innovators developing these digital solutions, the prospect of entering a market that offers a standardised pathway to reimbursement is an incentive to commercialise there earlier. For example, in Ireland, entrepreneurs nurtured here may be less inclined to take their products overseas first and instead, sell locally, creating benefits for local patients.
France and Belgium have already followed suit, with several Member States choosing to include telemedicine, AI solutions and robotics into their reimbursement frameworks. It is important now for Europe to set guidelines to avoid increasing fragmentation in the future. At EIT Health, we have established a pan-European task force which is setting recommendations for consistency in clinical trial protocol design across Member States for faster reimbursement.