D. Stern, Matthies, Julia Hagen, Brönneke, and F. Debatin depict the point of inflexion that the Digitale-Versorgung-Gesetz (DVG) will prospectively poise in global health care in their article ‘Want to See the Future of Digital Health Tools? Look to Germany’. Prior to the DVG, the German health care system was hinged by a severe comparative lag in digital advances; there simply was no incentive for manufacturers to adventure into a system that so heavily lacked the support of the medical community.
Perhaps if Covid had not happened, these laws would have passed unrecognized, however, the catalytic effect of the pandemic only evidenced the benefits that this digital development entails, in particular the gap that exists in the market for a remote monitoring scheme that will survive a lockdown (or several).
The increase in the number of apps employed in monitoring and care delivery will subsequently create an immense pool of ‘real world data’ which may debunk data from randomized controlled trials as the gold standard for regulatory decisions about new health care products.
This holds a risk; it opens the barriers for all software to accumulate real-world data of medical importance, which may lead to an increase of inefficient software holding personal information. Although this risk will not easily disappear, for any app to be included in the DIGA registry and to qualify for insurance coverage it must first obtain the CE mark, barriers of which have been raised by the recent enforcement of the MDR. In addition, it must demonstrate it secures data protection, information security, interoperability, and preliminary data on the benefits that the app provides. In other words, manufacturers are incentivised, but safety and efficacy are still protected by law.
Source: Harvard Business Review.
Subject Matter Expert
Maria Nyåkern, Ph.D. Founder & Executive Director LinkedIn
