Public Comment by Feb 4: ONC Health IT Safety Plan

ONC recently released its Health IT Patient Safety Action and Surveillance Plan for public comments, which are due by Feb 4, 2013. Comments can be sent to ONC.Policy@hhs.gov.

The report can be found HERE, as well as a brief Fact Sheet.  The report is related to the IOM's 2011 recommendations from Health IT & Patient Safety: Building Safer Systems for Better Care.

Highlights

Patient safety objectives

1. Use health IT to make care safer 
2. Continuously improve the safety of health IT

Increase the quantity and quality of data and knowledge about health IT safety

1. Make it easier for clinicians to report patient safety events and risks using EHR technology.
2. Engage health IT developers to embrace their shared responsibility for patient safety and promote reporting of patient safety events and risks. 
3. Provide support to Patient Safety Organizations (PSOs) to identify, aggregate, and analyze health IT safety event and hazard reports.
4. Incorporate health IT safety in post-market surveillance of certified EHR technology through ONC-Authorized Certification Bodies (ONC-ACBs).
5. Align CMS health and safety standards with the safety of health IT, and train surveyors. 
6. Collect data on health IT safety events through the Quality & Safety Review System (QSRS).
7. Monitor health IT adverse event reports to the Manufacturer and User Facility Device Experience (MAUDE) database.

Target resources and corrective actions to improve health IT safety and patient safety

1. Use Meaningful Use of EHR technology to improve patient safety.
2. Incorporate safety into certification criteria for health IT products.
3. Support research and development of testing, user tools, and best practices related to health IT safety and its safe use.
4. Incorporate health IT safety into medical education and training for all health care providers.
5. Investigate and take corrective action, when necessary, to address serious adverse events or unsafe conditions involving EHR technology. 

Promote a culture of safety related to health IT

1. Develop health IT safety priority areas, measures, and targets.
2. Publish a report on a strategy and recommendations for an appropriate, risk-based regulatory framework for health IT. 
3. Establish an ONC Safety Program to coordinate the implementation the Health IT Safety Plan. 
4. Encourage state governments to incorporate health IT into their patient safety oversight programs.  
5. Encourage private sector leadership and shared responsibility for health IT patient safety.

IOM to Address Safety of EHRs

Scot Silverstein from the Health Care Renewal blog posted about IOM's recently announced contract with ONC to "identify best policies and practices for improving healthcare safety when using electronic health records."

"Perhaps these studies should have been initiated, say, ten years ago, or at least before the beneficence of health IT and its capacity to revolutionize medicine was openly promoted by the past and current Administrations (the current one going so far as to institutionalize penalties for non adopters)?"

The IOM consensus study, entitled "Patient Safety and Health Information Technology," will be conducted by NAS staffers Samantha Chao, Joi Washington, and Erin Wilhelm:

"The IOM will review the available evidence and the experience from the field on how the use of health information technology (HIT) affects the safety of patient care and make recommendations on how public and private actors can maximize the safety of HIT-assisted health care services. The IOM's final report will be both comprehensive and specific in terms of recommended options and opportunities for public and private interventions that may improve the safety of care that incorporates the use EHRs and other forms of HIT."

While I agree that this effort should have been done long ago, I am glad to see it being addressed. There is much polarization about whether EHRs are the best thing since sliced bread or the worst thing to hit medicine since managed care. Perhaps this IOM study will address both the pros and cons of EHRs from a provider's perspective (though I don't think any of the study staff are providers). Health care providers need to have a voice that can be heard by the vendors and governments when we find that given instances of EHR usability are inefficient or unsafe, and maybe this study will recommendations to address this current gap.