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Navigating through regulatory frameworks for digital therapeutics and biomarkers.

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Title: Navigating through regulatory frameworks for digital therapeutics and biomarkers.
Authors: Koller, Cinja1 (AUTHOR) Cinja.koller@chuv.ch, Blanchard, Marc1 (AUTHOR), Hügle, Thomas1 (AUTHOR)
Source: Health Informatics Journal. Oct-Dec2025, Vol. 31 Issue 4, p1-19. 19p.
Subject Terms: *Computer software, Digital technology standards, Patient safety, Digital health, Telemedicine, Conceptual structures, Medical equipment laws, Government regulation, Biomarkers
Company/Entity: United States. Food & Drug Administration , European Union
Abstract: Background: Digital health technologies are often subject to regulatory requirements. Regulatory auditing processes are complex but necessary to guarantee quality, efficacy and safety of patients. Evolvements such as digitalized clinical trials, and digital biomarkers require a constant adaption of regulatory frameworks. Objective: This review aims to provide an overview on current regulations and standards for digital therapeutics and digital biomarkers, from technical development to market access. Methods: We conducted an unstructured literature review to identify the relevant guidelines, policies and standards for software based digital therapeutics and digital biomarkers. Results: The principal regulations governing software as a medical device are outlined in Chapter 21 of the Code of Federal Regulations by the US Food and Drug Administration, as well as the European Medical Device Regulation 2017/745. Regulatory pathways, such as the DiGA, are in the process of development, particularly for digital therapeutics, which fall within the purview of software as a medical device. Qualification of (digital) biomarkers is typically voluntary but can play a significant role in the development and approval of digital therapeutics. Conclusions: Fragmented, lacking and diverse regulations around digital biomarkers and digital therapeutics highlight the urge to harmonize and foster regulatory frameworks on an international level. [ABSTRACT FROM AUTHOR]
Copyright of Health Informatics Journal is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Education Research Complete
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DbLabel: Education Research Complete
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PubType: Academic Journal
PubTypeId: academicJournal
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  Data: Navigating through regulatory frameworks for digital therapeutics and biomarkers.
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  Data: <searchLink fieldCode="AR" term="%22Koller%2C+Cinja%22">Koller, Cinja</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> Cinja.koller@chuv.ch</i><br /><searchLink fieldCode="AR" term="%22Blanchard%2C+Marc%22">Blanchard, Marc</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hügle%2C+Thomas%22">Hügle, Thomas</searchLink><relatesTo>1</relatesTo> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Health+Informatics+Journal%22">Health Informatics Journal</searchLink>. Oct-Dec2025, Vol. 31 Issue 4, p1-19. 19p.
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  Data: *<searchLink fieldCode="DE" term="%22Computer+software%22">Computer software</searchLink><br /><searchLink fieldCode="DE" term="%22Digital+technology+standards%22">Digital technology standards</searchLink><br /><searchLink fieldCode="DE" term="%22Patient+safety%22">Patient safety</searchLink><br /><searchLink fieldCode="DE" term="%22Digital+health%22">Digital health</searchLink><br /><searchLink fieldCode="DE" term="%22Telemedicine%22">Telemedicine</searchLink><br /><searchLink fieldCode="DE" term="%22Conceptual+structures%22">Conceptual structures</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+equipment+laws%22">Medical equipment laws</searchLink><br /><searchLink fieldCode="DE" term="%22Government+regulation%22">Government regulation</searchLink><br /><searchLink fieldCode="DE" term="%22Biomarkers%22">Biomarkers</searchLink>
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  Data: <searchLink fieldCode="DE" term="%22United+States%2E+Food+%26+Drug+Administration%22">United States. Food & Drug Administration</searchLink> <br /><searchLink fieldCode="DE" term="%22European+Union%22">European Union</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: Background: Digital health technologies are often subject to regulatory requirements. Regulatory auditing processes are complex but necessary to guarantee quality, efficacy and safety of patients. Evolvements such as digitalized clinical trials, and digital biomarkers require a constant adaption of regulatory frameworks. Objective: This review aims to provide an overview on current regulations and standards for digital therapeutics and digital biomarkers, from technical development to market access. Methods: We conducted an unstructured literature review to identify the relevant guidelines, policies and standards for software based digital therapeutics and digital biomarkers. Results: The principal regulations governing software as a medical device are outlined in Chapter 21 of the Code of Federal Regulations by the US Food and Drug Administration, as well as the European Medical Device Regulation 2017/745. Regulatory pathways, such as the DiGA, are in the process of development, particularly for digital therapeutics, which fall within the purview of software as a medical device. Qualification of (digital) biomarkers is typically voluntary but can play a significant role in the development and approval of digital therapeutics. Conclusions: Fragmented, lacking and diverse regulations around digital biomarkers and digital therapeutics highlight the urge to harmonize and foster regulatory frameworks on an international level. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Health Informatics Journal is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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      – TitleFull: Navigating through regulatory frameworks for digital therapeutics and biomarkers.
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              Text: Oct-Dec2025
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