ECRI Calls for Stronger Safeguards for Digital Health Tools in Recommendations to Congress

ECRI, a nonprofit patient safety organization dedicated to advancing evidence-based care, submitted recommendations to Congress urging strengthened oversight and transparency requirements for digital health technologies.

In response to the House Energy and Commerce Subcommittee on Health's April 15, 2026, hearing, Healthier America: Legislative Proposals to Improve Public Health, ECRI provided lawmakers with policy recommendations and key patient safety risks related to the proposed Digital Health Screeners Act of 2026 and the regulatory landscape for digital health tools.

Growing Risks in a Rapidly Expanding Digital Health Market

As consumer-facing health technologies, including wearable devices and clinical decision support (CDS) tools, become more widely used, ECRI warns that gaps in regulatory oversight could lead to patient harm.

One major concern is the increasing availability of general wellness devices that measure or estimate physiologic parameters such as blood pressure, oxygen saturation, electrocardiograms, and blood glucose. While these tools may appear clinically equivalent to regulated medical devices, many fall outside the U.S. Food and Drug Administration (FDA) oversight framework, creating confusion for patients and providers alike.

“From a user perspective, there is often no visible distinction between a clinically validated device and one that has not undergone the same level of scrutiny,” Dr. Scott Lucas, ECRI’s vice president of device safety, noted in the statement, highlighting the risk of inappropriate clinical reliance on unvalidated data.

ECRI also raised concerns about the lack of mandatory reporting requirements for wellness devices. Unlike regulated medical devices, these products are not subject to standardized post-market surveillance, making it difficult to identify and address safety issues before they result in harm.

Transparency Gaps in Clinical Decision Support Tools

In addition to consumer devices, ECRI emphasized risks associated with CDS software increasingly used in clinical settings. While recent FDA guidance clarifies which tools fall outside regulatory oversight, it does not impose enforceable requirements for transparency.

ECRI cautioned that proposed expansions to exemptions for certain CDS tools, particularly those offering single recommendations, could further reduce oversight without ensuring that clinicians understand how those recommendations are generated.

Without access to information about underlying algorithms, training data, and performance across patient populations, clinicians may be more susceptible to automation bias, overreliance on technology that can undermine independent clinical judgment.

Policy Recommendations to Strengthen Patient Safety

To address these concerns, ECRI urged lawmakers to adopt several targeted policy measures:

• Establish a clear, public-facing classification system to distinguish clinically validated devices from general wellness products
• Expand oversight authorities to include risks associated with inaccurate physiologic data, not just physical or electrical hazards
• Require enforceable transparency standards for all CDS tools used in clinical care
• Mandate validation of device performance across diverse demographic groups to reduce disparities in care

ECRI emphasized that these steps are essential to ensure that innovation in digital health does not outpace patient safety protections.

Advancing Health Equity Through Better Oversight

ECRI also highlighted the disproportionate impact of current regulatory gaps on underserved populations. Evidence has shown that some widely used technologies, such as pulse oximeters, may perform less accurately in certain demographic groups, raising concerns about inequities in diagnosis and treatment.

As digital health tools increasingly supplement or replace in-person care in some communities, ensuring their accuracy and reliability across diverse populations is critical to preventing harm and advancing equitable care.

ECRI was invited to contribute to the April 15, 2026, hearing Healthier America: Legislative Proposals to Improve Public Health, held by the House Energy and Commerce Subcommittee on Health. ECRI’s submitted statement related to the Digital Health Screeners Act of 2026 was included in the hearing’s Documents for the Record. Read the full statement at the link.

Contact: Yvonne Rhodes, YRhodes@ECRI.org, Strategic Director of Communications & Operations