HIT Safety Administration (HITSA)

HITSA / HITSB White Paper - DRAFT

Achieving the national vision of healthcare transformation via Health Information Technology (HIT) has been difficult for healthcare delivery organizations because numerous barriers exist. In particular, the safety and effectiveness of Electronic Health Records (EHRs) and the accuracy of connected medical device data is increasingly being called into question. If there is a problem or patient injury due to incomplete or erroneous EHR data in a complex multi-vendor installation, where should the hospital turn for remediation? Who has the authority, resources, and expertise to perform a system safety assessment or root cause analysis of an EHR/medical device system? This analysis would require clinical, system engineering, HIT, and product expertise. When problems occur in EHR integration, it is not generally possible for hospital staff by themselves to determine the root cause.

The challenges faced by IT and BME (biomedical engineering) experts to effectively detect, investigate, and mitigate medical errors and adverse events in which medical device and HIT component-behavior contributes, hampers many investigations, even those in which medical device failures are not a root cause. Could the FDA help? The FDA manages medical device safety on a per-manufacturer or per-device basis. They don’t appear to have a process to investigate adverse events and perform a root cause analyses at a system-level of vendors, medical devices, non-medical HIT equipment, installation options, and clinical usage. And most importantly, work with all of these regulated and non-regulated parties to mitigate future risks as technologies and practices change.

A possible solution:

Reference examples
NHTSA: The safety challenges in HIT are similar to the problems in environments that depend on complex systems, such as the automotive industry. The mission of NHTSA http://www.nhtsa.gov/  is to “save lives, prevent injuries, reduce vehicle-related crashes.” To do so it must consider the effect on safety of factors as diverse as road surface composition, tire performance, signage, headlights, human factors, biomechanics, and, for when things don’t go well, crashworthiness, air bags, and child seats. Significant changes to the system must be evaluated in the context of all the other elements. NHTSA maintains data files and knowledge banks for research to improve vehicle safety, and has regulatory oversight.

ASIAS: Similarly, the FAA and other stakeholders created the Aviation Safety Information Analysis and Sharing (ASIAS) collaboration to share de-identified data from FAA, airlines, manufacturers, as well as publicly available data to improve aviation safety.

We envision the creation of an “HIT Safety Administration” (HITSA) (or HIT "Safety Board"), a public-private partnership that could, in collaboration with vendors, hospitals, FDA, NIST, ONC and FCC (and NLM and NSF) provide a convening environment and test bed for HIT systems prior to deployment and for solving problems when they develop. Proposed standards and technologies could be assessed and problems addressed prior to adoption. Root cause analysis of adverse events and near misses could be performed in collaboration with vendors, as needed. Product defects or configuration problems could be addressed horizontally and solutions coordinated across industry, instead of by each hospital-vendor pair. Facilitation of adverse event analysis involving HIT systems may require the application of technologies that have been successful elsewhere, such as “black box” recorders for network medical device/HIT data.

Implementation of truly interoperable and safe medical device/EMR systems will lower the cost of health care and accelerate innovation. This approach to safety can also provide the US with a healthcare manufacturing leadership opportunity.


Julian Goldman MD
Initial draft July 22, 2011, based on a presentation to the NITRD Health IT R&D SSG . Last updated, April 2014

Access the FDASIA WG presentation on Event Reporting Paradigms on healthit.gov.