Feds move nearer to patient-safety framework for health IT

Now that a majority of healthcare providers have installed electronic health-record systems, the federal government is inching closer to adopting a regulatory and patient-safety framework for computerized healthcare devices.

The latest move comes more than a year and a half after an Institute of Medicine report pointed out “unacceptable risks” posed by health IT systems under the status quo.

The Office of the National Coordinator for Health Information Technology at HHS today published a request for comments from the public as part of a joint effort it and the Food and Drug Administration and the Federal Communications Commission are undertaking to develop a congressionally mandated report on possible regulations “for health IT, including mobile medical applications.”

The report was required by the Food and Drug Administration Safety and Innovation Act of 2012.

Any public comments received will be funneled to a newly formed work group of the federally chartered Health IT Policy Committee, an ONC advisory panel.

The joint agency report should contain a “proposed strategy and recommendations on an appropriate, risk-based regulatory framework” for these health IT systems and mobile apps “that promotes innovation, protects patient safety and avoids regulatory duplication,” according to today's announcement, which was published in the Federal Register.

With the rapid adoption of health IT, the announcement said, “there is a growing need for the federal government to develop a coordinated approach to its oversight of health IT that promotes innovation, protects patient safety and avoids regulatory duplication.”

According to recent CMS data, more than half of physicians and other eligible professionals and 77% of eligible hospitals have been paid federal incentives to at least purchase and install a certified EHR system. The EHR incentive program, created under the American Recovery and Reinvestment Act, has paid out more than $14.6 billion so far.

The announcement raises more questions than provides answers for Dr. Scott Silverstein, a physician-informaticist and a frequent blogger on the impact of health information technology on patient safety.

“Why are we several years into a national rollout, with penalties for nonadopters, and a regulation/safety study is being framed only now?” Silverstein asked. “Why were people such as myself and like-minded colleagues ignored for years? What triggered this epiphany? Litigation?”

Silverstein specifically noted that the IOM found instances of health IT-associated harm had been reported, but “little published evidence could be found quantifying the magnitude of the risk.”

The IOM was commissioned by the ONC in 2010 to look into how healthcare IT affects patient safety. Its report, Health IT and Patient Safety: Building Safer Systems for Better Care, was released in November 2011.

Late last year, in response to the IOM report, the ONC released a Health Information Technology Patient Safety Action & Surveillance Plan that called for the ONC to work with the FDA to produce a report containing "a strategy and recommendations for an appropriate, risk-based regulatory framework for health IT." That broader plan, which will cover EHR systems, should be released in a month or two, according to an ONC spokesman. The report required by last year's FDA legislation, will be narrower and will focus more on medical devices, the spokesman said.

In March, an FDA official told a congressional panel that the agency planned to issue a final guidance on the regulation of mobile medical applications before Oct. 1, following up on a draft guidance the FDA issued in mid 2011.

The 2011 IOM report listed multiple barriers to the gathering of information about the risks of using health IT systems, including nondisclosure and confidentiality clauses in the contracts between health IT vendors and providers “that can prevent users from sharing information about health IT-related adverse effects.”

All of which prompts Silverstein to wonder, given that the safety and risk factors are unknown: “If we have no regulatory framework, then why are the brakes not put on the national (EHR) rollout?”

Comments in response to the ONC, FDA and FCC joint effort can be submitted until noon Aug. 31.

Public comments received will be reviewed by the new Health IT Policy Committee work group. That work group, formed in April, is to provide the three federal agencies with input on the types and likelihood of risks to patients posed by health IT, factors in a risk-based regulatory approach for health IT that would also promote innovation, and the avoidance of regulatory overlap.

The work group has scheduled meetings today and tomorrow.

Follow Joseph Conn on Twitter: @MHJConn