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Washington Debrief: ONC Moves Forward with Patient Safety Initiatives

November 19, 2013
by Jeff Smith, Director of Public Policy at CHIME
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Jeff Smith, Director of Public Policy at CHIME

ONC Moves Forward with Patient Safety Initiatives  When the Office for the National Coordinator for Health IT (ONC) published its Patient Safety Surveillance & Action Plan, government officials wanted the effort to be aimed at developing “shared goals and strategies for optimizing HIT safety and maximizing the potential of HIT to improve patient safety.” Since July, ONC has been busy coordinating various components of the plan, and last week, Jodi Daniel, Director of ONC’s Office of Policy and Planning, updated the Health IT Standards Committee on its patient safety work.

In one such project, ONC is partnering with MITRE to assess the feasibility of and options for establishing a public-private partnership that would provide a patient safety reporting infrastructure, governance rules and resources for engaging stakeholders. This joins two separate projects to perform aggregate analysis of HIT-related adverse event data in patient safety organization (PSO) databases. The projects are working to “identify types, frequencies, and underlying causes of HIT-related events in order to support public-private efforts to develop evidence-based measures for improving HIT patient safety,” Daniels said. The preliminary results are expected in March 2014.

In parallel, ONC has contracted with the Joint Commission (TJC) to conduct voluntary investigations of HIT-related events at hospitals/provider sites by performing an in-depth analysis of HIT-related events in its de-identified sentinel event database in order to increase understanding of the role of HIT in patient safety. Based on these activities, TJC will publish a research paper and develop educational materials that will be made widely available with preliminary results expected by January 2014.

Finally, ONC has developed draft versions of SAFER Guides, risk assessment tools developed for providers based on the latest evidence of HIT patient safety. A final release of SAFER Guides is expected early next year.

ONC to Extend Standards Work, Focus in 2014  During the November meeting of the Health IT Standards Committee (HITSC), ONC’s Chief Science Officer Doug Fridsma outlined a number of priority areas for the Standards & Interoperability (S&I) Framework. Fridsma detailed over 20 areas of standards development, categorized as being of “high,” “medium,” and “low” priority. Dr. Fridsma also previewed a few new areas of work, including an initiative to enable prescription drug monitoring programs (PDMPs) to more easily share data with health IT tools.

Writing in his blog after the meetings, HITSC Chair John Halamka said “Although we need to separate the ‘mediums’ into those we do and those we don't (do), there was uniform consensus that a focus on image exchange, quality measurement, referral workflow, record locator services, and care plans makes great sense,” among members of the HITSC.

Energy & Commerce to Hold mHealth Hearing  Amid the flurry of House and Senate oversight hearings regarding Healthcare.gov, some lawmakers are focused on more substantive healthcare and technology policies.

The House Energy and Commerce Committee's health subcommittee will evaluate FDA's regulation of mobile medical applications during a hearing today. Health subcommittee chairman Joe Pitts (R-Penn.) said the hearing will examine the FDA's final guidance on mobile medical apps, released in September, and how the agency plans to move forward with oversight in the area.

The committee will also discuss legislation recently introduced by Rep. Marsha Blackburn (R-TN) that would limit FDA oversight by exempting clinical and health software from the agency's purview. The Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act (HR 3303) borrows largely from the conceptual framework developed by the Bipartisan Policy Center, which CHIME helped develop. Beyond instructing FDA to focus on that narrow segment of medical applications, it codifies language that would exempt clinical and health software from FDA regulation.

The legislation defines clinical software as clinical decision support software or other software that captures, analyzes, changes or presents clinical data but that does not change the structure or the function of the body.

Health software is defined as any software that is not medical software or clinical software but still captures clinical data and acts as a platform for secondary data, according to the bill.

Upcoming CHIME Public Policy Briefing to focus on EHR Hardship Exemptions

It's FY 2014, Do You Know Where Your Certified EHR Is?

Date: 11/20/2013
Time: 12:00:00 PM - 1:00:00 PM ET

Session Speaker: Robert Anthony, Director of the Health IT Initiatives Group in the Office of E-Health Standards, Centers for Medicare & Medicaid Services

According to federal rules, hospitals that are eligible to participate in the Medicare EHR Incentive Program must meet meaningful use requirements to avoid the federally-mandated payment adjustments that begin October 1, 2014. To avoid payment adjustments next year, all eligible hospitals will have to begin collecting data by July 1, 2014, for a 90-day, quarter-based reporting period, regardless for which Stage or payment year they are attesting. Is your organization prepared? If not, there is good news. CMS has established EHR Hardship Exemptions and will be on-hand during this session to describe the program and who will be eligible. Hardship exceptions will be granted only under specific circumstances, and only if CMS determines that providers have demonstrated significant barriers to achieving meaningful use.

Learning Objectives:

  • Explain how payment adjustments are calculated based on MU participation start year
  • Describe the different categories of EHR Hardship Exemptions
  • Detail how eligible hospitals can apply for an EHR Hardship Exemption, if need be

Register here

Edited by Gabriel Perna

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