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# PhRMA Urges FDA to Clarify Digital Health Technology Standards
- URL: https://www.fdaweb.com/phrma-urges-fda-to-clarify-digital-health-technology-standards/
- Published: 2026-06-08T12:00:00.000Z
- Updated: 2026-09-14T13:40:41.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161274

Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on FDA to provide clearer regulatory expectations for the use of digital health technologies in drug development, arguing that adoption has lagged despite years of agency guidance and industry investment.

In [comments](https://downloads.regulations.gov/FDA-2026-N-2476-0040/attachment%5F1.pdf?ref=fdaweb.com) submitted to an FDA request for information on advancing digital health technologies (DHTs) in clinical investigations, PhRMA said wearable sensors, mobile applications, software platforms and other digital tools have the potential to expand access to clinical trials, improve patient engagement and generate richer clinical data. However, the group said uncertainty around evidentiary standards has slowed broader regulatory acceptance of DHT-derived data and endpoints.

"Despite years of effort by both industry and FDA, progress in using DHTs to inform regulatory decision-making has been limited," PhRMA wrote, noting that digital health technology-derived endpoints have not been incorporated into primary and secondary trial endpoints as widely as many sponsors anticipated.

The comments were filed in response to an FDA initiative launched in March seeking stakeholder feedback on how the agency can facilitate greater use of digital health technologies in studies supporting drug and biologic approvals.

In its comments, PhRMA urged FDA to adopt a more explicit, risk-based framework for determining whether a digital tool is "fit for purpose" in a given clinical trial setting. The organization said evidentiary requirements should vary according to factors such as the complexity of the condition being measured, the role of the data in the trial, the level of human oversight and the clinical significance of the endpoint being assessed.

The group also asked FDA to develop practical tools — including decision trees, templates, case studies and checklists — to help sponsors navigate the agency's expectations and promote consistency across review divisions.

In addition, PhRMA requested greater clarity on how FDA expects companies to manage software updates and other modifications to digital technologies during ongoing clinical trials.

A central theme of the industry's comments was the need for clearer guidance on digital endpoints. PhRMA said sponsors face uncertainty when determining whether DHT-derived measures should be classified as biomarkers, clinical outcome assessments or other endpoint categories. The organization urged FDA to better align terminology across agency programs and clarify how sensor-generated data and digital biomarkers fit within existing regulatory frameworks.

The trade group also called for more detailed guidance on validation requirements for digital endpoints, particularly novel measures that may lack traditional comparator data.

According to the comments, sponsors would benefit from FDA examples illustrating how DHT-derived endpoints have been accepted across different therapeutic areas and trial phases, as well as guidance on the use of composite endpoints that combine multiple digital measures.

Separately, the Biotechnology Innovation Organization (BIO) told FDA that years of workshops, pilot programs, demonstration projects and stakeholder meetings have generated substantial discussion around digital health technologies, but sponsors have seen limited transparency regarding how those lessons are being translated into regulatory policy.

[BIO urged](https://downloads.regulations.gov/FDA-2026-N-2476-0027/attachment%5F1.pdf?ref=fdaweb.com) the agency to publish summaries and analyses of lessons learned from prior workshops, Digital Health Technology Steering Committee activities, demonstration projects and regulatory submissions that incorporated DHTs, provided confidential commercial information is protected.

The biotechnology trade group argued that sponsors need greater visibility into FDA's experience evaluating digital technologies in real-world regulatory reviews.

Echoing concerns raised by PhRMA, BIO said FDA should provide clearer guidance on when DHT-derived measures can be used as primary or key secondary endpoints in pivotal studies.

The organization also called for more detailed statistical guidance covering digital endpoints, including application of the estimand framework, multiplicity adjustments, analysis of continuous and longitudinal datasets, management of intercurrent events, and approaches to missing data.

BIO said sponsors need practical pathways to reuse validation work across different patient populations, devices, software versions and contexts of use rather than repeatedly generating similar evidence packages.

The group further requested clearer standards for demonstrating interchangeability between digital tools, including FDA expectations regarding comparator selection, non-inferiority margins, performance metrics and reporting requirements.

BIO concluded that FDA should establish clear, risk-proportionate regulatory pathways for digital health technologies and outlined seven priorities:

- A unified, cross-center approach to DHT oversight.
- Risk-tiered templates for verification, validation and endpoint development.
- Explicit guidance on digital endpoints, multimodal measures and decentralized clinical trial workflows.
- Clear expectations for artificial intelligence and machine-learning transparency, monitoring and change management.
- Requirements to address equity, accessibility and representative validation populations.
- Expanded opportunities for formal and informal engagement with sponsors, supported by predictable feedback timelines.
- Greater international harmonization to support global drug development programs.

BIO argued that without greater regulatory clarity, the full potential of digital technologies to improve trial efficiency, increase patient participation and generate more meaningful clinical data could remain unrealized despite broad industry interest in their adoption.