HIMSS: New HIT framework must 'act in concert' with current device regs

Health IT products such as electronic health records and clinical decision support systems should be subject to a risk-based oversight framework that weighs factors such as "risk relative to intended use" with the intent to bring about patient safety, according to Scott MacLean, Chair of the HIMSS Board of Directors, and HIMSS President and CEO Steve Lieber.

That's the primary suggestion in a letter sent by MacLean and Lieber to U.S. Department of Health & Human Services Secretary Kathleen Sebelius this week as the federal government works to develop recommendations on health IT regulation as part of the Food and Drug Administration Safety and Innovation Act.

"We are aware that capabilities are continually evolving, and recommend that any new policy provide predictable processes for health IT products," the letter says. "In particular, how health IT products would move between any new and existing frameworks, towards increased or decreased regulation in accordance with evolving functionality."

MacLean and Lieber stress that the new oversight framework must "act in concert" with current medical device regulation framework, adding that the former can complement the latter process. They also say that HHS should work to avoid duplication with the Office of the National Coordinator's health information technology certification program.

"HIMSS applauds the various public-private efforts called for in FDASIA and implemented by your Department, particularly those focused on developing an appropriate and effective regulatory framework for health IT that protects patient safety, promotes innovation and avoids regulatory duplication. To be effective, this framework should:

  • Balance the costs and benefits of any program proposal;
  • Ensure clear, consistent and non-duplicative language and enforcement;
  • Be affordable to those expected to bear direct and indirect compliance costs; and
  • Avoid adding burdens that inhibit or delay improvements to systems that improve care delivery and safety."

In recommendations offered to the FDASIA workgroup in September, the Health IT Policy Committee said that there's no need for substantial new regulation of health IT, but closer scrutiny according to regulation already in place--with cross-agency collaboration. It added that technology should be assessed according to level of risk, and called for greater transparency in the process.

To learn more:
- read the HIMSS letter (.pdf)