How to Successfully Advance Digital Health Applications

The benefits of digital health applications are numerous and include the flexibility to self-monitor your illness from home with a mobile device. One caveat: Digital health applications (DiGA – in German: "Digitale Gesundheitsanwendungen") must abide by technical and legal frameworks to be recognized as such.  

In this MEDICA.de Interview, Dr. Benedikt Zacher explains the evidence requirements that must be met to ensure a successful implementation and describes the possible future of DiGAs.

Dr. Zacher, what specified criteria must healthcare tools meet to be recognized as DiGA under the Digital Healthcare Act?

Dr. Benedikt Zacher: There are several formal requirements: A digital health application (DiGA) must be a medical device of the lowest risk classes I or IIa. Starting in May, many DiGA providers will be subject to more complex certification processes according to the EU Medical Device Regulation (MDR).

They must also meet specific functional requirements to be included in the Fast-Track Process of the Federal Institute for Drugs and Medical Devices (BfArM). One essential requirement is that the application is designed for the patient and not for the medically savvy user or the physician. The DiGA must facilitate communication and patient guidance, thus enabling partial self-management of the diagnosis, therapy, or healing process. DiGA evidence requirements for the assessment are detailed on the BfArM website. 

What are the legal and regulatory conditions that must be met in the development process?

Zacher: Legislative changes mean that apps can now be prescribed by doctors and costs will be reimbursed through German health insurance. As a result, digital healthcare apps or consumer health apps aim to be certified as DiGAs or “apps on prescription” as these apps are often not certified. But the latter is the crucial point. During the development process, it is essential to start with the desired end result in mind and work backwards from there. This means that you define the medical purpose of the product, and developers should work backwards and consider the steps that must be completed by the end of the DiGA process. In the last part of this process are price negotiations with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), which approves reimbursement amounts. It is also important to incorporate data protection standards and information security during software development right from the start. According to the new MDR guidelines, quality management systems must likewise be certified in the future. 

What are the technical challenges in developing a DiGA?

Zacher: The challenges depend primarily on the type of application. This is contingent on the software complexity or whether it is combined with hardware. Many DiGAs are generally apps. That is why you must take a cross-platform approach and consider all possible requirements for a quality management system in the different versions. You should directly include and meet the requirements of the certification to facilitate an easy update integration at a later point. It is also important to consider software documentation as it relates to data protection and data security.

How can DiGAs improve the lives of patients?

Zacher: The Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) came into effect in 2010 and introduced the “app on prescription” as part of healthcare provided to patients. The basic idea was to use the benefits of digitization and enable patients to systematically use digital health technologies to better manage and track their health and wellness-related activities. The advantage is that the user is less dependent on the public health infrastructure. For example, chronic diseases require continuous monitoring. If the specialist clinic is too far away, DiGAs can step in to collect and transmit the necessary data, thus facilitating a certain level of self-management.

Are there current research projects that pertain to DiGAs?

Zacher: The introduction of the DVG was not the trigger for research projects that study whether a patient’s wellbeing can be improved by digitizing the diagnosis, therapy, and monitoring of chronic diseases. The DVG is actually the result of these types of projects. The DVG is a veritable revolution. Germany is the first country in the world to quickly approve highly sophisticated technical health systems with relatively low hurdles for a (preliminary) admission into the DiGA directory.

What are the trends in digital healthcare applications?

Zacher: The initial euphoria that prevailed 1.5 years ago has given way to some disenchantment. This is because it is quite elaborate to enter the DiGA Fast-Track. Second, the fast-track process costs a lot of money because it requires a comparative study that proves that the solution delivers on its promises. Third, one must narrow down the indication areas during development.  This shows that apart from fine-tuning, the types of indications also play a role in DiGA development. We are presently noticing a focus on areas with fewer existing product choices, meaning developers pursue a niche strategy. These are areas where pain is intense, and the gold standard is particularly expensive.

Another strategy – and one we also pursue at the DiGA Factory - is to not necessarily develop niche DiGAs but design them for a specific disease or to assist medical specialists. It might help to reduce costs if this approach can take advantage of synergies in special fields because there is no need to redevelop the same app over and over if you only need variations. After all, you will definitely have to deal with pricing pressures once a selection is made after the fast-track process.