D.C. Report: IOM Health IT Report Released, HITSC Seeks Comments, HIE Standards Confirmed

IOM Drops Long-Anticipated Report on Health IT and Patient Safety Washington was abuzz this week with the release of the Institute of Medicine’s 197-page report "Health IT and Patient Safety: Building Safer Systems for Better Care.” The much anticipated report said that current market forces are not adequately addressing potential risks associated with use of health IT and that more attention needs to be brought to patient safety and EHRs. IOM made ten recommendations (.pdf), including the need for HHS to develop a multi-stakeholder strategy within one year to “assess the impact of health IT on patient safety and minimizing the risk of its implementation and use.” Another recommendation would establish two new federal bodies: the HHS Health IT Safety Committee would set criteria for the safe use of HIT; while an independent federal agency modeled after the National Transportation Safety Board would investigate incidents. These recommendations were given in light of “mixed opinion on how FDA regulation would impact the pace of innovation but identified several areas of concern regarding immediate FDA regulation.” Some members of the report favored a scheme that gave FDA the authority to regulate EHRs as “Class III” devices – the most strictly regulated of medical devices – while others felt the FDA would likely restrict market innovation in health IT, which could also jeopardize patient safety.

However, Recommendation 9a states: “If progress toward safety and reliability is not sufficient as determined by the Secretary, the Secretary should direct the FDA to exercise all available authority to regulate EHRs, health information exchanges, and PHRs.” And 9b follows: “The Secretary should immediately direct the FDA to begin developing the necessary framework for regulation. Such a framework should be in place if and when the Secretary decides the state of health IT safety requires FDA regulation as stipulated in Recommendation 9a above.” See also, Dr. Farzad Mostashari’s response to the IOM report in a blog post on the ONC’s website.

CHIME is examining the IOM report for possible response. Please contact Sharon Canner or Jeff Smith for more information.

ONC Advisory Group Seeks Comments on Exchange Specifications Through a post on the Federal Advisory Committee Blog this week, the Health IT Standards Committee (HITSC) is seeking comments from anyone who has experience exchanging information through the Nationwide Health Information Network (NwHIN) using Exchange specifications and protocols. On September 28, 2011, the HITSC provided recommendations regarding standards and specifications for the nationwide health information network, via a transmittal letter (.pdf). As part of the transmittal letter, HITSC recommended that ONC perform further assessment of industry adoption, and deployment, operational, and administrative complexity of the Exchange specifications – especially from those who have implemented these specifications in organizations other than Federal agencies, and from organizations that have implemented a technology stack different from that represented in the Exchange specifications. ONC requests feedback on fourteen questions ranging from wanting to know the business function supported by Exchange in your organization to asking how easy or difficult the Exchange specifications were to understand, interpret, and implement. Find out more information on the Request for Comment here.