Progress on Health IT Patient Safety Action and Surveillance Plan
In July of 2013, the Office of the National Coordinator for Health IT (ONC) published the Health IT Patient Safety Action and Surveillance Plan. Since publication of the Health IT Safety Plan, the ONC has released a number of guides, reports and projects. Below is a summary of the various resources available to providers, vendors and developers.
- Guide by ECRI Institute on How to Identify and Address Unsafe Conditions Associated with Health IT. This Guide helps healthcare providers and EHR technology developers identify and report health IT-related events to PSOs.
- Report by RAND on Promoting Patient Safety Through Effective Health Information Technology Risk Management. This Report identifies challenges and success factors for implementing effective risk management related to health IT, including reporting to PSOs. Appendix A includes analysis by ECRI PSO of reports submitted during the project by participating entities.
- Guide by the National Center for Human Factors in Healthcare on The Role of Health IT Developers in Improving Patient Safety in High Reliability Organizations. This Guide makes 18 recommendations on how health IT developers can help their clients optimize the safety and safe use of their products and services, including by supporting reporting and working with PSOs.
- Nine Safety Assurance Factors for EHR Resilience (SAFER) Guides. These guides contain 158 recommended practices in areas of recognized risk. The self-assessment guides, developed by recognized experts, are based upon the best evidence available and are designed to help EHR users evaluate their own practices with regard to the safety of EHR technology itself, the safe use of EHRs, and continual monitoring and improvement.
- EHR Usability Toolkit developed under an ONC cooperative agreement with the National Center for Cognitive Informatics and Decision Making in Healthcare at the University of Texas Houston, and it is designed for usability evaluation, testing, measurement and design of EHRs in accordance with ONC certification requirements and NIST guidance.
- An ONC-funded review of published studies from January 2010 through August 2013, Health Information Technology: An Updated Systematic Review With a Focus on Meaningful Use, which found that health IT had statistically and clinically significant benefits, often associated with the meaningful use functionalities of clinical decision support, computerized provider order entry, patient access, lists, and reminders.
- As required by the FDA Safety and Innovation Act (FDASIA), ONC, FDA, and FCC published the draft FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework, in April 2014. The Draft Report published for comment proposed that reliance on ONC coordination and private sector capabilities was the preferred approach to oversight, with no new or additional reliance on regulatory oversight. Read Brian Ahier’s commentary on this draft framework.