Multi-layered digital solutions that support medical care processes have been available for quite some time. The Digital Health Care Act (Digitales-Versorgungs-Gesetz, DVG) and the Digital Health Applications Ordinance (Digitale-Gesundheitsanwendungen-Verordnung, DIGAV) create a legal basis that puts an end to political discussions about powers and procedural responsibility and at the same time makes it possible to offer a digital health application. Thanks to the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) approving the digital health application (DiGA) as a medical device through its fast-track process, it can be positioned in statutory health insurance providers’ standard care offerings and made accessible to their approximately 74 million policyholders as an ‘app on prescription’.
We will show you what the path of a digital application might look like, from the initial idea to the development process to approval as a medical device. You can also find out which access options are available using the BfArM fast-track application process, as well as alternative options for inclusion in standard care – and learn which prerequisites need to be met for this. We support you throughout all stages of the product process.
In the DiGA Interaction Room, we work with you to develop an innovative concept for implementing your ideas for a digital health application (DiGA) that is eligible for approval by BfArM. In addition, we also discuss the opportunities that the application would bring as well as individual options for your company.
In order to be reimbursed as a DiGA, a mobile application must meet certain criteria for a medical device as defined by law. This is somewhat of a challenge, as the legal definitions are stricter than common usage. In addition, there are shades of grey when it comes to mobile applications.
The health market is so heavily regulated and interspersed with so many different conditions to an extent to which almost no other target market can compare. A central regulation for giving medical applications access to statutory insurance policyholder markets was overdue. However, the access route into standard care is now clearly laid out. Read more about alternative market access routes in our blog post.
As well as developing your brand, it is crucial that you implement the right marketing measures to make your digital health application a success. You also need to factor in the legal regulations, such as the German Act on Advertising of Medical Products (Heilmittelwerbegesetz, HWG). We provide you with support from brand development to marketing to make your DiGA successful.
adesso’s DiGA process support continues with market monitoring and operation after it has been launched on the market. Market monitoring also includes proof of the positive care effects according to the DiGAV. This is documented, for example, using the standardised PICO process and (medical) studies that have been carried out and evaluated.
In addition, further market monitoring, post-market surveillance (PMS) and research on new findings about medical devices and comparable medical devices for the relevant indicators are carried out, as well as research on new findings in the medical field.
Receiving and evaluating feedback from doctors, patients and health insurance providers, for instance, enables corrections to be made swiftly and the risk assessment can be updated, if necessary. Tracking and analytics as well as regular system and product audits guarantee data protection, information security and usability. In addition, at least one unannounced audit by the designated body will be carried out within five years.
Find out how adesso recognises, opens up and promotes alternative business models in addition to the usual process support.