The interview partners
Prof. Dr. Patrick Da-Cruz is Professor of Business Administration and Healthcare Management at the Faculty of Healthcare Management at Neu-Ulm University of Applied Sciences (HNU) and Academic Director of the MBA program Leadership and Management in Healthcare.
Before joining the HNU, Mr. Da-Cruz worked for renowned strategy consultancies in the pharmaceutical/healthcare sector and in management positions in companies in the healthcare industry in Germany and abroad.
Dr. Dominik Strobl is a lawyer at Produktkanzlei in Augsburg and advises companies on all aspects of the life sciences sector. His focus is primarily on the advertising of medicinal products, healthcare compliance and all legal facets of the digitalization of the healthcare sector. In addition, he regularly publishes specialist articles on medical and pharmaceutical law topics and is a lecturer in the HNU education programme “Digitalization and AI in Healthcare”.
Which legal frameworks and regulations currently play a role in the context of e-health and digital health?
Dr. Strobl: e-health law is a cross-cutting issue, which means that standards from a wide variety of legal areas play a role. For example, the European legislator is primarily responsible for the regulation of medical devices and data protection, while the German legislator sets the framework conditions for specific applications such as digital health applications (DiGA), electronic patient files or electronic prescriptions. Last but not least, there are all kinds of sub-legislators in the medical field. For example, health insurance companies play a decisive role in electronic patient records, the Federal Joint Committee issues regulations on the prescribability of certain services in video consultations and the German Medical Council or the state medical associations must decide on the admissibility of remote treatment under medical professional law.
These examples show that we are confronted with an entangled legal framework in which the individual cogs often do not mesh well enough. In my opinion, the most decisive legal framework conditions are to be found in reimbursement and remuneration law, medical device law and data protection law. The General Data Protection Regulation and the Medical Devices Regulation in particular are relatively new standards that are still subject to further development through interpretation aids and, in particular, case law, so it will be exciting to see how they develop. In addition, more and more specific applications, such as the current electronic prescription, are being implemented in healthcare. The basis for this is usually the law of statutory health insurance. In addition, topics such as the advertising of therapeutic products and liability (product liability, but also the liability of the person providing treatment) are constantly being addressed.
What are the key hurdles that a new digital healthcare solution must overcome in order to enter the market? What needs to be considered during development?
Dr. Strobl: It depends. Some legal requirements, such as data protection, apply in principle to all digital healthcare solutions. From a regulatory point of view, it is also crucial whether or not the solution is a medical device. If the healthcare solution is a medical device, it is subject to a wide range of legal requirements. In particular, a medical device must be certified before it can be placed on the market. The interesting thing is that manufacturers can, to a certain extent, decide for themselves whether or not to place a medical device on the market because they give the product the medical (e.g. diagnostic or therapeutic) purpose that makes it a medical device, for example by advertising it. Particularly in gray areas such as the demarcation to wellness or lifestyle applications, manufacturers can control the regulatory classification. It is therefore essential to decide at the beginning of the development process whether the digital health solution is to become a medical device or not.
In addition to the regulatory issue of market access, the dimension of remuneration and reimbursement must also be taken into account. From the manufacturer's point of view, it is of course crucial from the outset that the product is reimbursed, i.e. that the manufacturer or any intermediary users are paid by the patient or payer. Ideally, the product becomes a “health insurance benefit”, i.e. is reimbursed by the statutory health insurance. This is the case, for example, with the apps listed in the “DiGA directory”.
In addition, the functionality of the planned product is particularly important. Developers need to familiarize themselves with the current and future regulatory environment at an early stage: Are there any potential professional law hurdles for doctors to use the product? What do the professional associations say about possible remote treatment? Are there certain applications, such as electronic patient records, that should be made interoperable? Will there be a transfer of data that may run counter to medical confidentiality? What are the VAT implications of the concept (especially with regard to a possible VAT exemption under Section 4 No. 14 UstG)? Are there any liability risks with regard to the way it works? And so on and so forth.
The “app on prescription” has been around for a few years now. What is your interim conclusion? What can we expect for the future?
Dr. Strobl: Since September 2020, certain digital medical devices, namely digital health applications (DiGA), can be prescribed at the expense of the SHI. These represent a special feature of health insurance law, particularly with regard to reimbursement - it has rarely been easier to obtain SHI funds.
Accordingly, the verdict must also be mixed. The goal associated with the introduction and in particular the various legal privileges of quickly implementing “apps on prescription” into the reality of healthcare was achieved. There are currently (01/2024) 58 apps listed in the DiGA directory, almost half of them in the area of “mental health”, where there are undoubtedly bottlenecks in care. The number of DiGAs and redeemed activation codes is also rising steadily. However, this interim result came at a high price. On the one hand, this is due to the fact that manufacturers are generally free to set the price for their DiGA in the first year, which means that the SHI's expenditure does not correlate with positive influences on the supply. On the other hand, DiGAs can also be provisionally included in the DiGA directory and therefore be reimbursed by the SHI without any evidence of positive supply effects at this time.
Healthcare policy has recognized the problem of free pricing in particular and has already addressed it through the DiGA framework agreement. The Digital Act passed in December 2023 also restricts free pricing; in future, pricing is to be more closely aligned with success criteria. In addition, the Digital Act contains some further adjustments for DiGA, which suggests that the legislator is still convinced of the concept of the “app on prescription”.
What current developments are there to report for the healthcare sector in the field of AI? What are the future legal challenges in this area?
Dr. Strobl: It is clear that the legal handling of AI is also and especially relevant for medical applications. After all, when it comes to diagnostics or therapy decisions, for example, there is an interest in ensuring that the information provided by AI meets the highest professional standards on the one hand and can be understood to a certain extent on the other. At the same time, AI offers enormous potential for increasing the quality of care, especially for such decisions. It is important to observe how the AI regulation, on which an agreement was recently reached in the trilogue process, influences medical applications.
In addition, AI in the medical field raises legal issues in two areas in particular. Firstly, there is the certification required for market access under medical device law, i.e. the assessment with regard to safety and performance. This inevitably relates to a specific point in time or technical status of the product to be assessed. Evolving software naturally raises the question of how or what should be certified at all. It is currently still disputed which types of AI can be certified under medical device law. There is also the question of who is liable for the (medical) statements made by an AI. The future legal situation here still appears to be relatively open, in particular the European AI Liability Directive proposed in September 2022 is unlikely to be negotiated further at present.
What other legal challenges are there in the area of e-health and digital health?
Dr. Strobl: There is a need for further regulation in many areas. For example, the applications envisaged in the “E-Health Act” of 2015 have still not fully arrived in the reality of healthcare, even though the pace has recently picked up noticeably with regard to electronic patient records and electronic prescriptions, for example. In addition, various antiquated regulations of medical law will need to be adapted to an increasingly digitalized healthcare system in the coming years. This applies, for example, with regard to the medical reservation or medical profession reservation, which currently reserves certain medical measures/decisions for doctors or alternative practitioners. A judicial or legislative decision is desirable here to clarify whether this reservation also applies to actions “performed” by machines or software. Another issue is the specifications for billing and reimbursement, which currently all too often still have an analog world in mind and make billing unnecessarily difficult. Quality assurance requirements are also sometimes not yet adapted to an increasingly digitalized healthcare world. More modern regulations that ensure legal certainty should be introduced here.
Thank you very much for the interview!
The content and statements presented in the interviews reflect the perspective of the interviewees and do not necessarily reflect the position of the editorial team.
