17 Apr Regulatory and diga trends To watch in 2024 with Jonas albert
Several regulatory digital health and DiGa trends have been emerging in 2024. There are new legal changes that digital health and life sciences startups need to pay close attention to. But what are they? Vision Health Pioneers Incubator was joined by Jonas Albert, Digital Health Consultant at fbeta and coach to our teams, to discuss some of the trends and changes he is foreseeing this year.
Digital health applications (DiGA) have so far been limited to medical devices in low-risk classes I and IIa. however, according to Jonas, this year “we will see the first preparations for the listing of DiGA with Risk-Class IIb (note: products can also be used for serious illnesses or decision-making in critical situations, like software-assisted dosing of insulin). Listings in 2024 are unlikely due to the length of studies needed and the lack of a preliminary listing phase.”
Remote patient monitoring-DiGAs will strive for listing, recognizing the importance of meeting the strict criteria outlined in the BfArM-FAQ. Solutions must supply a physician with information and benefit the patient directly.
It is highly likely that we will see the first listed DiPA (Digitale Pflegeanwendungen or Digital Care Applications) this year!
Investors are increasingly warming up to DTx (especially DiGA) as a Business Model and are more and more willing to finance reimbursement-driven Business Models
By the end of 2024, we will have systems for DTx reimbursement in place in the GSA region as well as in France and Belgium, which will represent a sizeable part of Europe, further increasing the viability of pan-European DTx-Business Models