Digital health apps and medical devices: compliance with european legislation and the german example (diga and digig)
| Páginas | 233-252 |
DIGITAL HEALTH APPS AND MEDICAL DEVICES:
COMPLIANCE WITH EUROPEAN LEGISLATION
AND THE GERMAN EXAMPLE (DiGA and DigiG)1
C B
Researcher, Centro de Direito Biomédico e Instituto Juridico
Faculdade de Direito, Universidade de Coimbra
C B / S R P
PhD student in Civil Law
Universidade de Coimbra
Sumario: 1. FUNDAMENTAL ASPECTS OF DIGITAL HEALTH APPLICATIONS (APP)
AND MEDICAL DEVICES (MD) 2. REGULATION OF MEDICAL DEVICES
IN THE EUROPEAN UNION (EU) 3. CASE STUDY: GERMAN APPROACH
(DiGA and DigiG) 4. FINAL CONSIDERATIONS 5. BIBLIOGRAPHY
The “Fourth Indus trial Revolution”2 is giving r ise to a series of ne w technologies
that allow atoms to be replaced by bits and dematerialize the world before us. This
1 El presente trabajo es parte del proyecto PID2022-136964NB-I00 El Derecho ante la Salud Di-
gital, Personalizada y Robótica (SALUDPYR) financiado por MCIN/ AEI /10.13039/501100011033/ y
por FEDER Una manera de hacer Europa, así como del proyecto de investigación “Contratación de Ser-
vicios de Telemedicina: Actualidad y Desafíos Jurídicos” (TED2021-129472B-00/MICINN) financiado
por MCIN/AEI/10.13039/501100011033 y por la Unión Europea NextGeneration EU/PRTR.
The present work is part of the project PID2022-136964NB-I00 ‘Law in the face of Digital,
Personalized, and Robotic Health (SALUDPYR)’ funded by MCIN/AEI/10.13039/501100011033/
and by FEDER ‘A way to make Europe,’ as well as the research project ‘Contracting Telemedicine
Services: Current Situation and Legal Challenges’ (TED2021-129472B-00/MICINN) funded by MCIN/
AEI/10.13039/501100011033 and by the European Union NextGeneration EU/PRTR.
2 “A Quarta Revolução Industrial é uma forma de descrever um conjunto de transformações em
curso e iminentes dos sistemas que nos rodeiam; sistemas que a maioria de nós aceita como algo que
sempre esteve presente. Mesmo que não pareça importante para aqueles cuja vida passa diariamente por
uma série de pequenos, mas significativos ajustes, a Quarta Revolução Industrial não consiste em uma
pequena mudança – ela é um novo capítulo do desenvolvimento humano, no mesmo nível da primeira,
da segunda e da Terceira Revolução Industrial e, mais uma vez, causada pela crescente disponibilização
234 Carla Barbosa / Stéfani Reimann Patz
virtualization of life is changing the way we constitute ourselves and live in society,
especially through the digitalization of social relationships and even of the individual.
This phenomenon is also impacting medical practice, especially in relation to
digital health interventions, which refer to the use of digital technology and connected
devices to improve health outcomes and the delivery of healthcare. In this context,
the use of Medical Devices (MD) - products used to diagnose, prevent, monitor, treat
or alleviate diseases - and Digital Health Applications (or Health Apps) - software
developed for electronic devices, such as cell phones, tablets and computers, which
offer health-related services - is a growing trend.3 Health care is following the
evolution of the Information Society, now called “Digital Health”, promising effective,
universal and social access to health.4
However, the adoption of Medical Devices and Digital Health Applications in
health care and, consequently, the digitization of the human body, raises concerns
regarding compliance with data protection requirements, information security and
user privacy. In this scenario, ensuring the safety and efficacy of these Devices and
Apps is crucial, highlighting the importance of regulation to protect public health
and promote the responsible use of these technologies.
By means of a literature review, this article aims to investigate the importance
of regulating Medical Devices and Digital Health Applications in the European
Union (EU), considering their fundamental role in guaranteeing the safety and
effectiveness of these devices in contemporary medical practice. It then goes on to
briefly analyze the Guidelines and certification processes required for marketing
in the EU, highlighting the challenges faced by companies in relation to regulatory
compliance. Finally, the specific case of Germany is analyzed, examining the DiGA
(Digital Health Apps) and DigiG (Digital Care Act) regulations and their impact on
the German healthcare system. Overall, the article aims to look at the implications
of these regulations and the challenges and opportunities for manufacturers and
regulators in the evolving context of digital health in the European Union.
e interação de um conjunto de tecnologias extraordinárias.” SCHWAB, K., A quarta revolução industrial.
Trad. Daniel Moreira Miranda. São Paulo: Edipro, 2016, p. 35. (“The Fourth Industrial Revolution is a
way of describing a set of ongoing and imminent transformations of the systems that surround us; sys-
tems that most of us accept as something that has always been there. Even if it doesn’t seem important
to those whose lives undergo a series of small but significant adjustments on a daily basis, the Fourth
Industrial Revolution is not a small change - it is a new chapter in human development, on a par with the
First, Second and Third Industrial Revolutions and, once again, caused by the increasing availability and
interaction of a set of extraordinary technologies.”)
3 Medical Devices (MD) range from simple instruments such as thermometers to more com-
plex equipment such as magnetic resonance imaging and implantable devices like pacemakers. Digital
Health Apps, on the other hand, can be used to monitor health data, manage medical conditions, provi-
de wellness information, offer support for healthy lifestyle changes, among other functionalities. These
apps can be aimed at healthcare professionals, patients or the general public.
4 HARARI, Y. N., 21 lições para o século 21. Trad. Paulo Geiger. São Paulo: Companhia das Letras,
2018, p. 45.
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