Healthcare Business News

Light touch regulatory scheme seems likely

By Joseph Conn
Posted: July 9, 2014 - 12:01 am ET

Healthcare providers that heavily invested in health information technology, along with the developers of those systems, will likely feel only a light regulatory touch from federal agencies seeking to devise a framework for patient-safety oversight and monitoring of those systems, recent developments indicate.

A final version of a federal regulatory position statement isn't due until winter, but a draft version passed through its 90-day public comment period this week, garnering some criticism, but passing muster with other stakeholder groups.

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On Tuesday, members of the federally chartered Health Information Technology Policy Committee approved a workgroup’s recommendations about the draft plan, moving it one more step toward a final decision.

The workgroup that formulated those recommendations was formed in April 2013 and includes Food and Drug Adminstration and Federal Communications Commission representatives.

Many of the healthcare information technology industry’s leading electronic health-system developers appear to be OK with the direction of the plan’s proposed three-tiered federal regulatory framework for their products and other healthcare IT systems.

Under the plan, the FDA would add nothing new to its regulatory portfolio, but would retain control over software for the medical devices it’s already regulating, such as bedside monitor alarms, that could pose relatively high risks to patient safety if glitches occur.

Most health IT products, however, including complex systems such as computerized physician order entry and medication management software, would fall under a lower-risk category, which, according to the proposed framework, would not be regulated by the FDA.

“Speaking for our nearly 40 member companies, we support many of the concepts proposed in the health IT framework and look forward to working with key stakeholders to move these important concepts forward,” said the Electronic Health Record Association, a vendors’ trade group affiliated with the Chicago-based Healthcare Information and Management Systems Society, in a July 7 letter (PDF) to FDA Commissioner Dr. Margaret Hamburg. The EHR vendors’ group said, for the sake of clarity, they would like to see in the final guidance more examples of the three risk categories outlined in the draft plan.

The vendors also supported the basic concept of a proposed Health IT Safety Center, provided that its role is further clarified as not including oversight or regulatory functions.

The workgroup’s chairman, Dr. David Bates, said the safety center should be a public-private partnership “outside of government,” but with government funding, a setup similar to that used for the National Transportation Safety Board. “We believe that the safety center has the potential to bring substantial value to the country,” Bates said, but it will be critical for the center to engage the key stakeholders effectively. It should avoid “interrupting relationships between vendors and customers” that the center will rely on as sources of information about IT safety issues, he said. Bates is the medical director of clinical and quality analysis, information systems at Partners HealthCare System, Boston.

The 34-page draft report, released in April, came in response to a mandate by Congress as part of the Food and Drug Administration Safety and Innovation Act of 2012 to look into patient safety while avoiding regulatory duplication.

ONC spokesman Peter Ashkenaz said the next steps are for the policy committee to review the workgroup’s recommendations and comments made during a meeting Tuesday and then forward the recommendations to the ONC. Then it, the FCC and FDA will review all the public comments and produce a final report by the end of the year, or early next year. The proposed FDASIA framework isn’t the only health IT patient-safety plan federal regulators have under consideration.

Last July, the ONC released its own 50-page “Health Information Technology Patient Safety Action & Surveillance Plan.” It called for establishing a Health IT Patient Safety Program with data collection capabilities within the ONC.

A $5 million appropriation request exists to fund the first year of the safety center in the HHS section of President Barack Obama’s fiscal 2015 budget now before Congress, Ashkenaz said.

Whether the patient safety center will be within the ONC, as its plan envisioned, or established outside the government as the FDASIA workgroup recommended, is as yet “undetermined,” Ashkenaz said.

Follow Joseph Conn on Twitter: @MHJConn

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