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Navigating through regulatory frameworks for digital therapeutics and biomarkers
Cinja Koller1, Marc Blanchard1, Thomas Hügle1
1Department of Rheumatology, University Hospital Lausanne, Lausanne, Switzerland.
Health Informatics Journal
|October 9, 2025
Summary
Regulatory frameworks for digital therapeutics and digital biomarkers are complex and evolving. Harmonizing these regulations globally is crucial for ensuring patient safety and fostering innovation in digital health.
Area of Science:
- Digital Health
- Regulatory Science
- Medical Device Regulation
Background:
- Digital health technologies, including digital therapeutics and biomarkers, face complex regulatory oversight.
- Ensuring patient safety, efficacy, and quality necessitates robust regulatory auditing.
- Evolving digital health landscapes require continuous adaptation of regulatory frameworks.
Purpose of the Study:
- To review current regulations and standards for digital therapeutics and digital biomarkers.
- To cover the lifecycle from technical development through market access.
- To provide an overview of the regulatory landscape.
Main Methods:
- Unstructured literature review.
- Identification of relevant guidelines, policies, and standards.
- Focus on software as a medical device.
Main Results:
- Key regulations include US FDA's 21 CFR and EU's Medical Device Regulation 2017/745.
- Specific regulatory pathways like DiGA are emerging for digital therapeutics.
- Digital biomarker qualification is often voluntary but impacts development and approval.
Conclusions:
- Current regulations for digital biomarkers and therapeutics are fragmented and diverse.
- There is a significant need for international harmonization of regulatory frameworks.
- Fostering consistent global regulations is essential for the digital health sector.
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