The FDA has made it official: digital health technologies (DHTs) are no longer a fringe consideration in clinical research — they are a strategic priority backed by congressional mandate. On March 31, 2026, the Federal Register published a formal request for information titled "Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products" (Docket No. FDA-2026-N-1234), signaling that CDER and CBER are actively shaping the next generation of clinical trial infrastructure around remote data acquisition and DHT-enabled endpoints.
For sponsors, CROs, and quality system professionals operating in the drug and biologics space, this is not background noise. This is a structural shift in how clinical evidence will be generated, evaluated, and submitted to the FDA. If your organization is not already positioning itself to operate in a DHT-enabled clinical environment, you are already behind.
Let me break down what is happening, why it matters, and — most importantly — what you should be doing about it right now.
What Is the FDA Actually Proposing?
The Federal Register notice stems directly from commitments made under PDUFA VII — the sixth reauthorization of the Prescription Drug User Fee Act, enacted as part of the FDA User Fee Reauthorization Act of 2022. Under PDUFA VII, both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) made explicit commitments to:
- Support the development and use of DHTs in drug and biological product clinical investigations
- Issue updated or new guidance documents addressing DHT validation, data integrity, and regulatory submission expectations
- Engage with stakeholders — including industry, patients, and technology developers — to inform that guidance
The March 2026 Federal Register publication is the FDA's formal mechanism to fulfill that last commitment. It invites public comment and information from a broad range of stakeholders on questions including: how DHTs should be validated for use in clinical trials, what data standards should govern DHT-collected data, how patient burden and equity considerations should factor into DHT design, and how sponsors should submit and document DHT-related evidence in INDs and NDAs/BLAs.
Citation Hook: Under PDUFA VII, FDA's CDER and CBER are formally committed to issuing guidance that supports the integration of digital health technologies into clinical investigations for drugs and biological products — a mandate that directly shapes sponsor obligations for clinical trial design and regulatory submission.
Why DHTs Are Reshaping Clinical Research
Digital health technologies in the clinical trial context include wearable sensors, mobile applications, electronic clinical outcome assessments (eCOAs), implantable devices that transmit data, and telehealth platforms used to conduct decentralized or hybrid clinical trial visits. These tools enable remote data acquisition — capturing physiological, behavioral, and patient-reported data outside of traditional clinical sites.
The opportunity is significant. According to a 2023 report by Deloitte, decentralized clinical trials (DCTs) — which rely heavily on DHTs — can reduce trial timelines by up to 30% and meaningfully increase patient retention by reducing the geographic and logistical burden of participation. The FDA itself has noted that DHTs can improve the quality and quantity of clinical data by enabling continuous, real-world monitoring rather than episodic clinic visits.
A few statistics that frame the stakes:
- The global digital health market was valued at approximately $211 billion in 2022 and is projected to exceed $780 billion by 2030, according to Grand View Research — underscoring the scale of technology investment already flowing into this space.
- Over 40% of clinical trials initiated since 2021 have incorporated at least one decentralized element, according to data from the Tufts Center for the Study of Drug Development, with that proportion rising steadily each year.
- FDA received more than 100 DHT-related regulatory submissions through its Digital Health Center of Excellence (DHCoE) in fiscal year 2023 alone, reflecting the volume and pace at which sponsors are already bringing these technologies to the regulatory table.
- Patient dropout rates in traditional clinical trials average 30%, but trials using DHTs and remote monitoring have demonstrated dropout rates as low as 10–15% in some therapeutic areas, per published clinical literature.
These numbers reflect an industry that is already running — with or without fully mature regulatory guardrails. The FDA's PDUFA VII initiative is, in part, an effort to ensure those guardrails are built before adoption outpaces oversight.
The Regulatory Gap DHTs Expose
Here is where I want to offer some analysis that goes beyond what the Federal Register notice itself articulates.
The core challenge with DHTs in clinical investigations is not technological — it is evidentiary. Sponsors and regulators alike must be able to answer a deceptively simple question: Is this device measuring what we claim it measures, and is that measurement fit for its intended regulatory purpose?
This question implicates several regulatory frameworks simultaneously:
| Regulatory Dimension | Applicable Framework | Key Challenge for DHT Integration |
|---|---|---|
| Device validation | FDA DHT guidance (2023); 21 CFR Part 11 | Establishing analytical and clinical validation for novel endpoints |
| Data integrity | 21 CFR Part 11; ICH E6(R3) GCP | Ensuring audit trails, access controls, and data traceability for remotely acquired data |
| Clinical endpoint qualification | FDA Biomarker Qualification Program; CDER/CBER DHT guidance | Demonstrating that a DHT-derived endpoint is a valid surrogate or primary endpoint |
| Patient-reported outcomes | FDA PRO guidance (2009, updated) | Aligning eCOA/ePRO instruments with validated paper-based equivalents |
| Cybersecurity | FDA cybersecurity guidance (2023) | Protecting patient data integrity and device functionality from cyber threats |
| Equity and access | PDUFA VII commitments; FDA diversity action plan guidance | Ensuring DHT use does not systematically exclude underrepresented populations |
The patchwork nature of this regulatory landscape is precisely why the FDA's PDUFA VII commitment to issue consolidated, DHT-specific guidance is so significant. Right now, sponsors must navigate across multiple guidance documents, none of which were written specifically for the use case of DHTs as clinical investigation tools. The forthcoming guidance — which the March 2026 Federal Register request is designed to inform — is expected to provide a more integrated framework.
Citation Hook: The integration of digital health technologies into clinical investigations currently requires sponsors to reconcile guidance from at least five distinct regulatory domains — including 21 CFR Part 11, ICH E6(R3), FDA's 2023 DHT guidance, and FDA's cybersecurity framework — creating a compliance complexity that forthcoming PDUFA VII guidance is expected to address.
What the FDA Wants to Hear From Industry
The Federal Register notice is not just a policy announcement — it is an active request for information. The FDA is soliciting stakeholder input on a range of specific topics. Understanding what the agency is asking tells you a great deal about where the regulatory gaps currently lie and where future obligations will fall.
Key areas the FDA has flagged for public comment include:
1. DHT Validation Standards
The FDA is seeking input on what constitutes adequate analytical and clinical validation for DHTs used to collect data that will support regulatory decisions. This includes questions about how validation evidence should be generated, documented, and submitted. For sponsors, this signals that DHT validation packages will likely become a standard component of IND and NDA/BLA submissions.
2. Data Standards and Interoperability
FDA is interested in whether existing data standards — such as CDISC CDASH and SDTM — are adequate for DHT-derived data, or whether new standards are needed. This is a critical operational question: if your DHT generates data in a format that cannot be mapped to CDISC standards, your submission could face significant review delays.
3. Patient Burden and Diversity
The agency is explicitly asking how DHT design can be optimized to reduce patient burden and improve diversity in clinical trial populations. This reflects the broader FDA commitment under the 2022 reauthorization act to address health equity in clinical research. Sponsors should expect that diversity action plans and DHT usability assessments will increasingly be reviewed together.
4. Regulatory Submission Expectations
Perhaps most practically, FDA is asking how sponsors should document and submit DHT-related evidence across the regulatory submission lifecycle — from IND through NDA/BLA and into post-market commitments. This is the "how do we actually do this in a submission" question that many sponsors are currently asking without clear answers.
Implications for Your Quality Management System
For organizations operating under ISO 13485 or 21 CFR Part 820 — or those building quality systems for combination products or drug-device combinations — the FDA's DHT initiative has direct quality system implications.
If you are a drug or biologics sponsor who is integrating a DHT into a clinical investigation, you need to consider:
Design Controls and Risk Management Even if the DHT itself is developed by a third-party vendor, your quality system must address design validation evidence for the specific use case in your trial. ISO 14971 risk management principles apply to the clinical use of DHTs, and your risk file should address failure modes specific to remote data acquisition — connectivity failures, patient misuse, cybersecurity incidents, and data loss scenarios.
Supplier and Vendor Management DHT vendors are, in effect, critical suppliers to your clinical program. Your vendor qualification process should include an assessment of the vendor's software development lifecycle (SDLC), their 21 CFR Part 11 compliance posture, and their ability to provide audit-ready documentation. I have seen sponsors enter Phase II trials with DHT vendors who have never undergone a regulatory audit — this is a material risk that quality teams must address upstream.
Data Integrity Infrastructure Remote data acquisition introduces data integrity challenges that are different in character from traditional EDC systems. Your quality system must address how DHT-generated data is authenticated, timestamped, transmitted, stored, and protected from unauthorized modification. This is 21 CFR Part 11 territory, but it is also ICH E6(R3) GCP territory — and the two frameworks do not always speak the same language.
SOPs and Training Clinical site staff and patients are both "users" of DHTs in a trial context. Your SOPs need to address DHT onboarding, troubleshooting, data query resolution, and device malfunction procedures. Patient-facing training materials must be validated for readability and comprehension — particularly for diverse patient populations.
Citation Hook: Sponsors integrating digital health technologies into clinical investigations must ensure their quality management systems address DHT supplier qualification, remote data integrity controls, and device-specific risk management under ISO 14971 — requirements that existing GCP and 21 CFR Part 11 frameworks address only partially.
What I Am Telling My Clients Right Now
At Certify Consulting, where I have worked with more than 200 clients across the drug, biologics, and medical device sectors, I am consistently advising sponsors at all stages of clinical development to take three immediate actions in response to this FDA initiative:
Action 1: Conduct a DHT Regulatory Readiness Assessment
Before your next IND submission or protocol amendment, assess whether your DHT integration plan is defensible under current FDA guidance — and where the gaps are relative to expected forthcoming guidance. This means reviewing your validation evidence, your data standards mapping, your Part 11 controls, and your vendor qualification documentation. Do not wait for the final guidance to land before starting this work.
Action 2: Submit Public Comments to the Federal Register Docket
This is an underutilized opportunity. The FDA is actively soliciting industry input to shape guidance that will govern your submissions for the next decade. Organizations with substantive operational experience using DHTs in trials have knowledge that regulators genuinely need — and submitting well-crafted comments is one of the most direct ways to influence how the guidance is written. If you need support drafting regulatory comments, this is exactly the kind of work my team does.
Action 3: Align Your DHT Strategy With Your Clinical Operations and Regulatory Affairs Teams Early
One of the most common failure modes I see is DHT selection happening in clinical operations in isolation from regulatory affairs and quality. A technology that is operationally elegant may be regulatorily undefendable if it lacks a validation package, generates non-CDISC-compliant data, or is built on a software platform that cannot meet Part 11 requirements. Cross-functional alignment early — ideally at the protocol design stage — is the single most cost-effective investment you can make in DHT readiness.
The Bigger Picture: Where This Is All Heading
The FDA's March 2026 Federal Register notice is one data point in a larger trajectory. The agency has been systematically building its DHT regulatory infrastructure since at least 2019, with milestones including the establishment of the Digital Health Center of Excellence in 2020, publication of the DHT guidance for drug and biological product development in 2023, and the PDUFA VII commitments that underpin the current initiative.
The direction of travel is clear: DHTs will become a standard feature of modern clinical trials, and regulatory expectations for their validation, documentation, and submission will become increasingly specific and enforceable.
Sponsors who invest now in building DHT-capable quality systems, validated technology partnerships, and staff with DHT regulatory fluency will have a meaningful competitive advantage — shorter development timelines, richer datasets, and more defensible submissions.
Those who wait will find themselves scrambling to retrofit compliance into programs that were built without it.
If your organization is navigating DHT integration in clinical investigations and you want expert guidance on regulatory strategy, quality system alignment, or IND/NDA submission support, I encourage you to reach out to us at Certify Consulting. Our team has the regulatory depth and operational experience to help you move quickly and confidently.
For additional context on how evolving FDA digital health policy intersects with your quality management obligations, see our related coverage on ISO 13485 and software-related quality system requirements on this site.
Frequently Asked Questions
What is PDUFA VII and why does it matter for digital health technologies in clinical trials?
PDUFA VII is the seventh iteration of the Prescription Drug User Fee Act, enacted as part of the FDA User Fee Reauthorization Act of 2022. It includes explicit commitments from CDER and CBER to support and issue guidance on the use of DHTs in clinical investigations — making DHT regulatory development a congressionally mandated FDA priority through at least 2027.
Do I need to validate my DHT before using it in an FDA-regulated clinical trial?
Yes. FDA's existing DHT guidance (2023) and anticipated forthcoming guidance both make clear that DHTs used to collect data supporting regulatory decisions must be analytically and clinically validated for their specific intended use. Validation evidence is expected to be submitted as part of IND and NDA/BLA packages where DHTs are used as primary or secondary endpoints.
How does 21 CFR Part 11 apply to data collected by DHTs in clinical trials?
21 CFR Part 11 applies to electronic records and electronic signatures used in FDA-regulated activities. DHT-generated data that will be submitted to FDA or used in regulatory decision-making must meet Part 11 requirements for audit trails, access controls, data authenticity, and record retention. Sponsors should assess their DHT vendor's Part 11 compliance as part of vendor qualification.
What data standards should sponsors use for DHT-generated clinical trial data?
FDA has not yet issued final standards specific to DHT data, which is one reason the March 2026 Federal Register notice solicits stakeholder input on this question. Currently, sponsors are expected to map DHT-derived data to CDISC standards (CDASH/SDTM) where possible. Sponsors using DHTs that generate non-standard data formats should engage early with FDA through pre-IND or Type B meetings to agree on acceptable data submission formats.
How can public comments to the FDA's March 2026 Federal Register request influence future guidance?
FDA uses public comments to identify gaps in current guidance, understand industry operational realities, and refine policy positions before issuing final guidance documents. Substantive, specific comments from sponsors with hands-on DHT trial experience can directly shape how validation requirements, submission expectations, and data standards are articulated in final guidance — making comment submission a high-leverage regulatory affairs activity.
Last updated: 2026-04-15
Source reference: Federal Register, Vol. 91, No. XX, March 31, 2026 — "Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information." Available at: https://www.federalregister.gov/documents/2026/03/31/2026-06184/advancing-the-use-of-digital-health-technologies-in-clinical-investigations-for-drugs-and-biological
Jared Clark
Principal Consultant, Certify Consulting
Jared Clark is the founder of Certify Consulting, helping organizations achieve and maintain compliance with international standards and regulatory requirements.