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Introduction —the digital transformation of medicine

My diagnosis, my therapy, my DiGA = My health!

Rapidly growing volumes of medical data, coupled with new possibilities for their evaluation and monitoring of individual therapies in the form of digital health applications (DiGA), are contributing to the increasingly sophisticated optimisation of medical care. Digitalisation is thus increasingly forming the basis for a desirable, individualized optimisation of diagnostics and therapies. Medicine is entering a new phase of development: while the quality of medical care was long determined primarily by the varying skills of individual physicians, a phase of increasing standardisation followed in the 1970s. Rapid advances in decoding the human genome as the biological basis of human life are now creating the foundation for a highly differentiated, data-driven approach to delivering optimal care, shaped by the biological variability of the individual patient.

The resulting spirit of innovation impacts not only biologists and physicians, but also health IT and data specialists. For individualized diagnostics and therapies to become reality, several prerequisites must be met: In addition to an in-depth understanding of biological principles and tools to decipher them, access to considerable volumes of diverse data of different origins as well as the management and processing of such data must be guaranteed. Building on these vital fundamentals, diagnostics and therapeutics can be controlled and monitored via apps or other digital health tools. This is where digital health applications, (known by their German acronym “DiGA”) come into play.

The realisation of these exciting developments requires comprehensive regulatory innovation and adaptation. A balance must be struck between medical benefits on the one hand, and data security and privacy protection on the other. The willingness of government and legislators to take on this task has been further advanced by the COVID-19 pandemic. It has provided the digital transformation of medicine with a momentum previously unknown, at least in Germany. In addition to a better understanding of the biological foundations of life, the digitalisation of medicine is being driven above all by two central, independent developments:

1. A vastly increased demand for sovereignty on the part of patients, requiring increased transparency based on digital information; and

2. Technological quantum leaps in computing and data storage coupled with ubiquitous access to data via smartphones.

Increased patient sovereignty

Fear and anxiety about illness and death have mystified the subject of “health” for centuries. Patients “went for treatment”, often blindly trusting their doctors. By creating and using their own language, physicians contributed to the mystification of their “art of healing”. Patients did not demand transparency and doctors had no real interest in providing it. The “sovereign patient” is thus a rather recent phenomenon—at least in Germany. Changes in patient attitudes and expectations are evolving rapidly, to a large extent as a result of the digitalisation of many other aspects of life.

In this respect, the COVID-19 pandemic has served as an accelerator. Physicians’ information monopoly is increasingly being challenged by apps, bots, and other tools. Patients are using tools to become better informed. Questioning and challenging a treating physician is becoming the norm rather than the exception. At the same time, people are experiencing the benefits of digitalisation in other aspects of their everyday lives. As such, making appointments with a doctor digitally is becoming just as standard as online banking. Direct communication with the doctor without leaving one’s own home, a certified electronic doctor’s note, a digitally renewable prescription—all of these create value for patients and people will want to retain many of these digital offerings that emerged during the pandemic. For healthcare providers, these developments translate into a considerable increase in “online” offerings and create both new opportunities and challenges for healthcare delivery.

Looking ahead, it is clear that digital options will drive fundamental change in the practice of medicine over the coming years. Similar to other technologies that can be applied in medicine, digitalisation is merely a means to an end—the technical basis for better healthcare, through increased quality and efficiency in medicine. Digital technologies are needed to realize the enormous potential of personalized medicine resulting in better care, and catering to people’s desire for transparency, efficiency and convenience. These benefits are the essential ingredients for a desirable form of “digital humanism”, which continues to focus on people rather than technology.

The broad use of digital technologies will help meet the justified demands of informed patients for safety and transparency, in combination with optimized, i.e., personalised, medicine for the individual. Digital options will contribute to enhancing both the sovereignty and confidence of people dealing with the commodity their “health”. Digitalisation of healthcare is not an end in itself.

Quantum leaps in digital technology

Cloud computing has created a new foundation for the use of digital technologies. Almost unlimited computing power and storage capacity are now available to users worldwide. In addition, the widespread distribution of mobile devices provides ubiquitous access to data in the cloud, irrespective of time and place. These technologies can be accessed by anyone—both for themselves as well as for others.

For the documentation and storage of medical data, this technological innovation enables a fundamental paradigm shift: Whereas medical data previously always had a direct link to its place of origin (where it was typically also stored), medical data can now be stored and processed centrally, independently of its place of origin, i.e., on a patient-specific basis. Data access and use are no longer determined by the location of data acquisition, but rather by the identity of the individual from whom the data originated. If authorized, these data can be processed and analysed by anyone via mobile devices. This, in turn, creates the data-driven basis for individually configured apps and other digital support tools for monitoring personalized diagnostic and therapeutic medical interventions.

The cloud-based explosion of computing power with its almost unlimited computing and data storage capacity, coupled with ubiquitous, decentralized, and mobile data access are the technological drivers of the coming digital transformation of medicine.

Digital health applications in standard medical care

Increased patient demand for sovereignty coupled with technological quantum leaps in computing and data storage, in conjunction with ubiquitous access to data have enabled the development of digital health applications (DiGA). As part of a comprehensive digital strategy of the German Federal Ministry of Health (BMG), which includes the introduction of a national electronic patient record (ePA) as well as the electronic prescription (eRezept), Germany’s legislature has created the possibility of integrating DiGA into the standard care of patients throughout the statutory health insurance system in a system-compliant manner. In Germany DiGA have been prescribed by doctors and reimbursed by statutory health insurers since mid-October of 2020.

A Fast-Track evaluation procedure was developed specifically in consideration of the dynamic development of digital innovations. Administered by the German Federal Office for Drugs and Medical Devices (BfArM), the initial assessment process does not require a completed proof of benefit, but can initially be limited to the evaluation of a clear benefit hypothesis supported by systematic data evaluation. Since certification of any DiGA in accordance with the Medical Device Regulation (MDR) is a prerequisite, as are strict specifications related to cybersecurity and data protection, harmful effects of the applications are virtually impossible. In order to further minimise risk, the Fast-Track procedure has been restricted to DiGA of classes I and IIa—i.e., medical devices outside of the highest risk categories under medical device law (MDR).

The integration of DiGA into standard, insurer-reimbursed care has put the German healthcare system in a unique leadership position globally. Accordingly, developments in Germany are being followed closely, not least by the German legislature itself. In the coming years, the focus will be on gaining experience with digital health tools in medical care whilst assessing actual medical benefits and the associated acceptance of such products among patients, physicians, and therapists. Cost-benefit analyses will be part of a comprehensive and ongoing assessment, as will questions of patient adherence and compliance.

Possible subsequent steps, such as the extension of the approval process to higher risk digital health applications (MDR Class IIb and III DiGA) as well as the continuation of the Fast-Track process as a whole, will depend directly on the documented experiences.

DiGA VADEMECUM

In the coming months and years, the focus will be on introducing DiGA as a “prescribable app” within the intended legal framework. The breadth of experience gained will directly depend on the number of DiGA developed and ultimately approved. And that brings us to the purpose of this book.

Written as a lean guide from concept, to approval, to successful product, the DiGA VADEMECUM is designed to support the development and dissemination of digital health applications (DiGA). It is a guide for application developers from start-ups as well as established companies. By clearly outlining all necessary steps from ideation to successful launch, the DiGA VADEMECUM also creates valuable insights for financing partners from the venture capital and private equity communities, as well as potential distribution partners from the pharmaceutical and medical technology industries. The work is also of interest to representatives of health insurance companies, who will be tasked with weighing benefits and costs of new digital tools. Ultimately, the DiGA VADEMECUM creates valuable insights for physicians and therapists who not only need to learn to prescribe DiGA thoughtfully and appropriately, but also to deal with their digital outputs in the interest of improving healthcare for their patients.

The “vademecum”, Latin for “walk with me!”, is a format dating back to the Middle Ages. It stands for a handy book format that can be carried around as a practical companion. First used in the Middle Ages for theological and liturgical writings, the format later became established primarily for medical manuals. From the Vademecum of Special Surgery and Orthopedics (Ziegner 1919), to the Vademecum for Pharmacists (Schmidt-Wetter 1975), to the Vademecum for Oncology (Schleucher et al. 2015), the format has not lost its relevance. While best practices in healthcare in the Middle Ages focussed on bloodletting, urinalysis, and healing herbs, this Vademecum provides guidance on the development and implementation of digital tools.