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planned to issue a final guidance on the regulation of mobile medical applications before Oct. 1, following up on a draft guidance the FDA issued in mid 2011.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.
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