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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