DiGA VADEMECUM E-Book

Jan B. Brönneke

• Herausgeber: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft mbH & Co. KG
• Kategorie: Fachliteratur
• Sprache: Englisch

Seitenzahl: 286

Veröffentlichungsjahr: 2021

Beschreibung

The "prescribable app" has arrived! Digital health applications (known by their German acronym, DiGA) are now accessible to the 73 million beneficiaries of Germany’s statutory healthcare system. Pioneering public policy is creating compelling new opportunities for innovation and driving digital transformation within Europe’s largest healthcare market – this is where this book comes in! Written by deep domain experts who helped shape the core DiGA policy framework and its implementation, this book is a streamlined guide to developing and disseminating digital health applications - from concept, to approval, to successful digital product. Designed for DiGA developers in both start-ups and established companies, the necessary steps from ideation to successful market launch are described. Edifying and clearly structured, the DiGA VADEMECUM also provides valuable insights for investors and financial partners from the venture capital and private equity sectors as well as for potential distribution partners from the pharmaceutical and medical technology communities. Finally, the DiGA VADEMECUM is also an invaluable resource for physicians and therapists who want to learn not only how to prescribe DiGA in a meaningful way, but also how to use digital feedback in the service of delivering better care to patients. DiGA VADEMECUM - A Must-Have for Digital Leaders in Healthcare!

Leseprobe

Jan B. Brönneke | Jörg F. Debatin | Julia Hagen Philipp Kircher | Henrik Matthies | Ariel D. Stern

DiGA VADEMECUM

How to Launch Digital Health Apps in the German Healthcare System

With contributions by

Kai Heitmann | Denitza Larsen | Ecky Oesterhoff | Philipp Stachwitz

Medizinisch Wissenschaftliche Verlagsgesellschaft

The Authors

Jan B. Brönneke, LL.M.

Prof. Jörg F. Debatin, M.D.

Julia Hagen

Philipp Kircher, Dr. jur.

Henrik Matthies, Ph.D.

Prof. Ariel D. Stern, Ph.D.

With contributions by

Kai Heitmann, M.D.

Denitza Larsen

Ecky Oesterhoff

Philipp Stachwitz, M.D.

MWV Medizinisch Wissenschaftliche Verlagsgesellschaft mbH & Co. KG

Unterbaumstraße 4

10117 Berlin

www.mwv-berlin.de

ISBN 978-3-95466-614-0 (eBook: PDF) ISBN 978-3-95466-615-7 (eBook: ePub)

Bibliographic Information of the German National Library

The German National Library (Deutsche Nationalbibliothek) has listed this publication in its German National Bibliography. Detailed bibliographic information is available online at http://dnb.d-nb.de

© MWV Medizinisch Wissenschaftliche Verlagsgesellschaft Berlin, 2021

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Product/Project Management: Bernadette Schultze-Jena, Susann Weber, Berlin

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Please address all comments and criticism to:

MWV Medizinisch Wissenschaftliche Verlagsgesellschaft mbH & Co. KG, Unterbaumstraße 4, 10117 Berlin, [email protected]

Disclaimer

This book presents the authors’ perspectives on the topic of ‘digital health applications’ after over a year of preparation before the launch of Germany’s first DiGA, with updates for the English-language edition following nearly a year of experience. The text explicitly does not represent the views of the Federal Ministry of Health or other public health institutions, nor does it constitute legal advice; it was written by the authors to the best of their knowledge and understanding.

Acknowledgements and Foreword

We are deeply grateful to Denitza Larsen, whose patience and project management were invaluable to the completion of the English language edition of this book. This book would also not exist, if Ariel D. Stern would not have supervised the translation with her unique understanding of multiple healthcare systems and her enduring effort to bring this project to live.

We further acknowledge superb support from Christian Nagelstrasser, Claudia Dirks, and the entire team at the Medizinisch Wissenschaftliche Verlagsgesellschaft, in particular Bernadette Schultze-Jena and Thomas Hopfe, for their exceptionally professional assistance and the unbelievably speedy realisation of this book.

In addition to the political leaders in the Bundestag, German Federal Ministries, and other authorities and organisations involved, we would like to thank the following individuals in particular, whose personal commitment made a significant contribution to the creation of the DiGA Fast-Track (in alphabetical order): Dr. Jan Hensmann, Dr. Lars Hunze, Christian Klose, Dr. Wolfgang Lauer, Dr. Wiebke Löbker, Dr. Gottfried Ludewig, Sophia Matenaar, Thomas Renner and Thomas Süptitz.

This book was written by the DiGA experts of the health innovation hub (hih), who have closely advised the Federal Ministry of Health (BMG) and the BfArM, which is responsible for the Fast-Track, since the first draft of the Digital Healthcare Act (DVG) in May 2019 and have supported its implementation to date. As such, the authors have waived author’s fees. After all, it’s all about the cause: better healthcare through the broadest possible use of digital health applications!

The entire hih team hopes you enjoy reading this book!

Berlin, September 2021

Dear Reader,

We are delighted to share the English language edition of the DiGA VADEMECUM with you and to bring the DiGA concept and regulatory approach to the international digital health community.

Since the publication of the German DiGA VADEMECUM some things have changed — yet much has remained unchanged! We have seen the launch of roughly 20 different DiGA and the market continues to evolve rapidly. While the first DiGA were launched by German start-ups, we are now seeing the internationalisation and professionalisation of the industry, with great interest from established pharmaceutical manufacturers and potent medical technology players.

Although parts of the world have been fortunate to experience the rollout of COVID-19 vaccines in recent months, the long shadow of the pandemic will accompany us for many more years to come. Indeed, the protracted nature of the pandemic and its accompanying disruptions to routine healthcare continue to underscore the value of a more digitalised healthcare system broadly and the value of more digital, remote, and patient-centred solutions, such as DiGA, in particular.

Beyond DiGA, the digital transformation of the German healthcare system continues to progress. This year alone, we are witnessing the rollout of the electronic patient record (ePA), the launch of e-prescriptions, as well as ongoing interest and enthusiasm for the (EUR 4.3 billion!) Hospital Future Act (KHZG) and the opportunities it will create for digitisation in the inpatient setting. In the medical device industry, the switch from the old EU Medical Device Directive (MDD) to the new EU Medical Device Regulation (MDR) was completed in May 2021. While the full transition to each of these new aspects of the healthcare landscape will take time, the metaphorical trains have left the station. And while digital transformation initiatives are not ends in and of themselves, they can and will be the means to a more transparent, more patient-centered, and more effective healthcare system.

We hope that you will find the English language version of the DiGA VADEMECUM helpful and we look forward to working together in the interest of building better healthcare everywhere.

Prof. Dr. Ariel D. Stern

Director, International Health Care Economics, hih

Associate Professor, Harvard Business School

Dr. Henrik Matthies

Prof. Dr. Jörg F. Debatin

Managing Director, hih

Chairman, hih

The Authors

Jan B. Brönneke, LL.M.

Jan B. Brönneke, a lawyer and economist, has worked as a manager at the German Federal Joint Committee and a law firm specialising in healthcare law. He previously conducted research on the further development of health technology assessment at the University of Bremen‘s Collaborative Research Center 597 “Statehood in Transition”. He is now an expert on legal and economic issues at the hih.

Prof. Jörg F. Debatin, M.D.

Jörg F. Debatin is Chairman of the hih. He is one of the earliest digital pioneers in the German healthcare sector, having transitioned the University Medical Centre Hamburg-Eppendorf to completely paperless operations in 2011. He later served on the boards of various medical technology companies, most recently as global CTO of GE Healthcare.

Julia Hagen

Julia Hagen was formerly the Digital Health Coordinator at bitkom e.V., Germany’s digital trade industry association. She is a political scientist and an expert in regulatory affairs and the political aspects of healthcare with previous posts in London and Paris. She is a connoisseur of the digital health scene in Germany and the hih‘s secret weapon for impossible projects.

Philipp Kircher, Dr. jur.

Philipp Kircher is a lawyer and expert on data protection in healthcare. After training stations in the Federal Ministry of Health and the Federal Joint Committee, he worked in two Berlin law firms specializing in healthcare law. At the hih, he is responsible for all of the finer points of the SGB V (German Social Code) and the GDPR (European General Data Protection Regulation).

Henrik Matthies, Ph.D.

Henrik Matthies, a serial entrepreneur (Jodel, Mimi Hearing Technologies), pioneered digital prevention in Germany with Mimi and is one of the country’s earliest digital health entrepreneurs. Previously, he was a manager at Bertelsmann for five years, earned his doctorate at RWTH Aachen University, and is now Managing Director of the hih.

Kai Heitmann, M.D.

Kai Heitmann is one of Europe‘s most renowned experts on interoperability and international standards. He is a physician and before joining the hih, was involved in the introduction of electronic patient records in Austria, Switzerland and the Netherlands, among other countries.

Ecky Oesterhoff

Ecky Oesterhoff is a veteran of the hospital IT world, most recently as CIO of BG Kliniken and product manager of HELIOS Kliniken, and previously as both a manufacturer and operator of hospital IT solutions. At the hih, he is responsible for all hospital topics.

Philipp Stachwitz, M.D.

Philipp Stachwitz is an anesthesiologist and pain therapist. Prior to the hih, he was responsible among other things, for the development and management of the staff unit Telematics, today‘s department “Digitalisation in Healthcare” of the German Medical Association (BÄK), as well as advisor to Germany’s gematik, and health start-ups. At the hih, he is responsible for the outpatient sector, where he continues to work one day a week as a physician.

Prof. Ariel D. Stern, Ph.D.

Ariel D. Stern is a health economist and Associate Professor at Harvard Business School. She holds a Ph.D. from Harvard University, where she wrote her doctoral dissertation on the economics of healthcare and the regulation of medical technology. Her research is at the intersection of regulation, firm strategy, innovation, and digital technology in the healthcare sector.

Table of contents

1Introduction—the digital transformation of medicine

2I don’t have time for this! An overview

3A turning point for the German healthcare system

4Hello, I am new here, how does the German healthcare system work?

5Pathways for digital solutions to enter the statutory (regulated) healthcare market

6Development of digital health tools

6.1Involvement of care expertise—ask a doctor or …

6.2Involvement of patient expertise

6.3Hospitals—digital health tools

6.4Interoperability and data formats—the interaction of people and systems

6.5Data protection and information security “by design”

6.6Regulation of medical devices

7The DiGA Fast-Track

7.1The definition of a DiGA

7.2Basic requirements

7.3Positive care effects

7.4Application for inclusion in the DiGA Directory

8The DiGA is listed—now what?

8.1And that was just the beginning: Price negotiations

8.2And who will prescribe me now? Change of perspective: Ambulatory care

8.3From prescription to DiGA

9Buy my DiGA; it’s very good! Marketing of digital medical devices

9.1Clash of cultures—modern marketing vs. the Therapeutics Advertisement Law

9.2What could possibly go wrong?—legal consequences

9.3The Therapeutics Advertisement Law

9.4Advertising regulations for DiGA

10The electronic patient record and the telematics infrastructure —a look beyond the DiGA horizon

10.1Secure e-mail communication among healthcare providers through KIM

10.2The electronic health card

10.3The electronic patient record (ePA)

10.4There was something else: The e-prescription

11Summary and outlook

Literature

Websites

1

Introduction —the digital transformation of medicine

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.

2

I don’t have time for this!An overview

With the DiGA VADEMECUM we would like to address the whole spectrum of digital health application (DiGA) topics from different perspectives within the healthcare system. Fortunately, as authors we do not have to limit ourselves to theory here, but can draw on our respective experiences in the (inter-)national healthcare system before each of us joined the hih. In addition to advising companies, many of us have worked in a start-up or corporate environment or managed hospitals, pharmacies, or inpatient providers. We have all learned: if you want to develop a digital health application, you have to understand relevant topics in both breadth AND in depth. Reading this chapter will therefore not be sufficient. Our apologies. But to find what you are looking for faster, we have summarized the subsequent chapters for you below. In addition to regulation, a whole range of tasks and challenges await founders and innovators—most of which have to be mastered in parallel—be it the development of a first prototype, securing financing, HR, taxes, recruiting, office hunting and all the other areas that also require your full attention. But without paying close attention to the topics described in this book, your digital health application will not be able to successfully enter the German healthcare system.

Next to the financial sector, the healthcare system is the most regulated market in Germany—and for good reason: It deals with one of the highest value goods we have—health. Not all hurdles are necessary; some were erected by entrepreneurs who started here 20–30 years before you, became successful, and now want to keep out competition—including innovative, digital competition. But the vast majority of regulations exist to ensure that products and services in and around the healthcare system are safe, of high quality, and have been scientifically proven to be effective, and to handle the entrusted (health) data extremely sensitively.

You will have to read through this entire book to understand the connections in detail. There are no shortcuts. Some of it is necessary, sometimes tough, regulation. But much of it is written (hopefully) pragmatically in order to enable people like you to more quickly launch good, innovative digital health applications that will help many thousands, possibly millions, of people manage their disease better. Because that’s what it’s all about.

Chapter 3 A turning point in the German healthcare system

Why is there suddenly a Fast-Track, how is digitalisation perceived by physicians, health insurers, hospitals, and patients? What other digitisation projects are pending in the German healthcare system?

Until 2016, there was no viable way to get digital health application (DiGA) into the statutory health insurance market. Since 2018, a broad array of digital legislation has been passed and brought into its implementation phases. Some statutory health insurers have been piloting digital health applications for longer than other players, but they have mainly done so out of marketing budgets and in the absence of proper regulation. The remaining players tend to be skeptical, in part because technology in the healthcare system did not always deliver what it promised. In addition to the introduction of DiGA, electronic patient record (ePA) infrastructure for all statutorily insured individuals (> 70 million Germans) was launched in 2021, which could establish a new digital health ecosystem. And then in 2022, electronic prescribing (e-prescription) will be introduced nationwide.

Chapter 4 Hello, I’m new here. How does the German healthcare system work?

In the German healthcare system, customers or users are (almost) never the ones who pay directly for the services and solutions provided—or rather, they do so only indirectly via their health insurers, which cover 100% of all necessary healthcare spending. And the customer/user in most cases needs a healthcare provider to prescribe a digital health application. Physicians and psychotherapists are thus the gatekeepers, and they must see added value in the prescription. How payment flows and customer relationships work is largely organized by a self-governance body made up of the federal associations of health insurers , physicians, and hospitals. In addition, there are local governments, states, and the federal government, all of which influence healthcare system mechanisms at different levels. And finally, there are two largely isolated markets: the outpatient and inpatient sector(s), each of which function differently. It’s complicated, but you can’t operate without at least a rudimentary understanding of these players and their interrelationships.

Chapter 5 Assistive technologies, methods, digital health application— pathways to statutory healthcare for digital solutions

In addition to the digital health application (DiGA) Fast-Track, there have been and continue to be other ways to get innovative products into care, and some of them may be relevant to your product. We present the alternatives, and discuss how digital health applications fit into these existing frameworks.

Chapter 6 Development of digital health tools

We’ll explain areas that are critical in the healthcare system and how they vary significantly from how digital products are normally distributed, used, and paid for. Whether your product is Fast-Track material or not, in this chapter we summarize the requirements that all digital health tools must meet if they are to succeed in the first healthcare market (with formal reimbursement) or the second healthcare market (of self-paying users).

In many areas, it is enough for two businesspeople to have a good idea and get started. This is fundamentally different in the healthcare context. You should have medical expertise in your team as early as possible, or tie experts closely to your work. Patients in Germany rarely pay privately for (digital) healthcare services, but instead expect their health insurer to cover all health-related costs. However, the health insurers usually only cover such costs for services that are prescribed by a doctor. And physicians rarely prescribe such services unless they support the physician’s own work or they are convinced of their benefit to patients.

Just as important as understanding healthcare providers motivations and behaviors is understanding the actual target group for digitals health tool(s): patients. Only by addressing their needs and their (disease)-specific requirements at an early stage can a digital health tool and a DiGA be developed that not only fulfill formal requirements, but are also wanted and used by patients—because such products provide tangible benefits.

The German inpatient sector (hospitals) functions significantly differently than the outpatient sector, i.e., the care provided in in doctors’ offices. If your digital medical device has points of contact with the inpatient sector, or even if it is to be used primarily in the context of discharge management, the background and specifics of the inpatient sector summarized here should be taken into account.

Digital health applications (DiGA) thrive on collecting and communicating data or having data available from other sources. But this is only possible if everyone adheres to a framework that defines how and which data is exchanged. The magic word is “interoperability”. This chapter explains what it is, what ingredients you should have on board, and what role international standards play. Above all however, it is clear that one is not alone in these questions, but can participate in and learn from a large community of experts.

There are many good reasons why data protection and data security are such valuable commodities in the healthcare system. You will spend a considerable amount of time setting up the development process and your organisation in a data protection compliant manner. You will need good— and when in doubt, external—data security experts to interrogate and continuously improve the existing practices and processess. It is best to pay attention to data protection and data security specifications from the start during the development of the DiGA (Privacy by Design and Default). We summarize the most important points for you.

An essential feature of a DiGA is that certification as a medical device has already taken place. This process will keep you busy both just as long and just as as intensively as the later Fast-Track application and will probably already begin in the first year after founding your company. You should deal with this topic as early as possible during product development in order to avoid costly adjustments of your product and especially to your development process at a later stage. We give an overview of the most important aspects of software as a medical device.

Chapter 7 The Digital Health Application (DiGA) Fast-Track

You have developed your product, CE-certified it as a medical device, prepared a scientific evaluation, gained initial practical experience, understood your clinical target group—and now feel ready for the Fast-Track? In this chapter, we explain key facts about the application process, based on the Federal Institute for Drugs and Medical Devices (BfArM) guide.

First, we turn to the legal definition of what constitutes a digital health application and explain its four essential criteria.

In addition to meeting the definitional requirements of a DiGA, there are a number of other fundamental requirements, most of which are already relevant in the medical device certification process, but which must be met in a differentiated manner in the (DiGA) Fast-Track process.

Rarely given much thought in the early stage product development, the production of scientific evidence becomes more important the closer your product gets to the statutory healthcare market. Data collection in initial “pilot studies” should be planned in parallel with product development, as should approaching renowned scientific institutions as partners for generating scientific evidence, at the latest in the run-up to Fast-Track application submission. In this chapter, we explain what is already known about positive care effects. In the coming months, more will emerge as best practice, and some scientific methods that are specific to the requirements and possibilities of digital health applications will be tested at scale for the first time through the Fast-Track.

Chapter 8 The DiGA is listed—now what?

Being listed in the DiGA registry is a key milestone, but your journey has not ended yet. Long-term success or failure will likely be determined by the first 12 months thereafter.

Some DiGA are only conditionally provisionally included in the Fast-Track for the first 12 months. Only if subsequent evidence confirms what was defined as a claim in the application, can a DiGA become permanently available to be prescribed and used in the German healthcare system. Why the evidence should not only validate minimal claims and how to be well prepared for price negotiations with the National Association of Statutory Health Insurance Funds (the second major milestone in the life of a DiGA)—are explained in this chapter.

It is not enough to have a good product with a large number of Weekly Active Users (WAU) and the blessing of the Federal Institute for Drugs and Medical Devices (BfArM). If you can’t clearly demonstrate added value for doctors and psychotherapists, they will hardly ever prescribe your DiGA. We give you insights into the everyday life of an outpatient physician in Germany and show you what you need to do to properly address this crucial target group.

You’ve convinced healthcare providers to prescribe your DiGA. But how exactly does the prescription process for a DiGA work—and as a manufacturer, what do you need to do to ensure that the DiGA is both prescribable and that you are bill health insurers? The DiGA manufacturers’ associations and health insurers, together with the National Association of Statutory Health Insurance Funds, have agreed in advance on a uniform technical procedure that works with physicians’ existing IT infrastructure and meets all data protection requirements.

Chapter 9 Buy my DiGA; it‘s really good! Marketing of digital medical devices

In the vast majority of markets, there are few restrictions on product advertising. This is different in medical device and medical product marketing. The Therapeutics Advertisement Law also applies to DiGA and defines requirements for marketing and communication. Non-compliance can result in severe penalties. This chapter is therefore relevant not only to those selling DiGA, but also for all C-level leaders who are liable for their company’s actions. In addition, some further restrictions for advertising inside a DiGA and tracking are defined.

Chapter 10 Electronic patient record and telematics infrastructure—a look beyond the DiGA horizon

The DiGA-Fast-Track is not the only digitalisation project in the German healthcare system. Even more fundamental and potentially impactful will be the finalisation of the domestic telematics infrastructure (TI) and, as its first major application, the electronic patient record (ePA). The ePA has the potential become the missing motherboard of the German healthcare system: a connector through which data flows freely between silos and is analyzed in a structured way, through which patients can decide who gets access to which data, and establishing a missing link between outpatient physicians, pharmacists, hospitals, nurses, and more. As such, this could create a unique, publicly-run digital health ecosystem. Where we are, how