Facing a dramatic rollback of federal regulations for developers of certified health information technology (HIT), the Texas Medical Association is sounding the alarm for patient safety and undue physician burden.
Among those developers, entities that develop electronic health record (EHR) platforms would be subject to significantly fewer mandates.
Namely, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) seeks to eliminate 34 of 60 certification criteria for EHR systems under the Health IT Certification Program. These deletions include regulations that require EHRs to:
- Promote information exchange necessary for coordination of care;
- Keep patients’ family health history embedded within its system;
- Be designed with usability and safety in mind;
- Include tools that feature decision support interventions; and
- Remain user friendly.
“TMA supports reducing unnecessary regulatory burden and promoting innovation in health information technology. However, the burden reduction in this proposal weakens the ability of ASTP/ONC to enforce critical baseline criteria that physicians and other users have come to expect,” TMA wrote in comments to the agency.
ASTP/ONC announced the Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash Prosperity Proposed Rule, also known as HTI-5, last December. The office says its changes aim to “reduce burdens, offer flexibility to both developers and providers, and support innovation through the removal and revision of certain certification criteria and regulatory provisions.”
However, TMA contends in its comment letter that by removing development guardrails, HTI-5 could jeopardize “baseline safety, reliability, and interoperability” across HIT – while placing burden on physicians, not HIT developers, to ensure health care technology remains safe and effective.
For instance, HTI-5 proposes relaxing rules around clinical information reconciliation, the process that compares and corrects data like medications and allergies when an EHR receives data from external sources. Removing reconciliation requirements increases the risk of data loss or duplication.
“Once certification requirements are removed, vendors … are no longer obligated to implement or sustain [safety] capabilities,” TMA stated in the letter. “In real-world clinical environments, especially emergency departments and inpatient settings, clinicians reasonably assume that externally sourced data have undergone some level of reconciliation. When that assumption is no longer valid, patient safety is compromised.”
Additionally, HTI-5 proposes removing existing “model card” requirements that mandate artificial intelligence (AI) developers disclose how their platform models are designed and tested, among other transparency rules. Instead, the agency recommends shifting toward new, more relaxed standards that “would allow more creative AI-enabled interoperability solutions,” per ASTP/ONC.
However, reducing transparency requirements “shifts responsibility for assessing algorithmic risk entirely to clinicians and health systems without transparency on how decision support is generated,” TMA voiced in its comment letter.
Instead, TMA recommended ASTP/ONC update its requirements to “reflect technology changes as related to AI and machine learning.”
The comment period closed Feb. 27, and ASTP/ONC has 60 days after that to revise HTI-5 , a process TMA will continue to monitor.
For more information about HIT, see TMA’s dedicated HIT webpage.
Alisa Pierce
Reporter, Division of Communications and Marketing
(512) 370-1469