Translation of a-t 2025; 56: 37-8

Proof of the benefit of digital health applications of a "sobering" quality¹

In theory, digital health applications (e a-t 8/2024a) can sensibly supplement medical therapy and contribute to the self-management of diseases. According to the umbrella organisation of the providers, there is at least one randomised controlled study for each of the applications that have been permanently added to the list of digital health applications published by the Federal Institute for Drugs and Medical Devices (BfArM).² The lobby association feels that the quality of evidence is ensured with this "over-fulfilment of regulatory requirements" – case-control and observational studies and the like would be sufficient, for example^2,3 – and inclusion in the list of digital health applications published by BfArM (currently 43⁴).² The assessment of the methodological quality of the randomised studies and data evaluated by BfArM in a three-month fast-track process is, however, sobering from the perspective of the health insurance providers and various working groups.^1,5 The reservations: there is a high potential for bias, for example in unblinded studies and when the focus is exclusively or primarily on endpoints that are not recorded using objective measuring methods but rather are reported by the users themselves (cf. deprexis, a-t 2025; 56: 37).^5-7 This strategy can be sensible where it is appropriate, but it decreases the reliability of the results.⁶ There are no comparisons of digital health applications in the same area of indication.⁸ High drop-out rates also give rise to fears that it may be difficult to motivate patients to use the unlocked digital health applications on a regular basis in everyday healthcare.⁶ If participants in digital health application studies are recruited online rather than through medical practices, they are more likely to be comfortable with digital technologies and the results may not be able to be generalised.⁵ The overall unsatisfactory level of significance of the proof of benefits is, among other things, the result of the requirements in the fast-track process being very low.^6,9 They circumvent assessment routines that have been established by the statutory health insurance providers for drugs, such as benefit assessments by the Federal Joint Committee.⁹ In light of the "low risk potential" and the assumed "comparatively low costs"* of digital health applications, the legislator has deemed it "disproportionate" to apply comparatively high evidence requirements to prove the required positive care effect, like for example the evidence of the additional benefit for drugs with new active substances.³ This results in a conflict of objectives: on the one hand, insured persons have an entitlement as soon as a digital health application is included in the official list, but on the other hand the statutory health insurance providers must ensure that the measures funded by the insured community are economical, expedient and medically necessary.¹ In any case, we cannot find sufficient evidence of the increase in sovereignty for patients and the easing of the strain on the health system alleged by the lobby association of the digital health application companies,¹⁰ –Ed.

©  arznei-telegramm (Berlin/Germany), May 2025, protected by copyright laws.