Last week I reviewed some aspects of the possible impact of Patient Safety issues that may impact on the PCEHR.
This is found here:
Since that blog last week there have been three developments.
First we have had recognition that the approach to the PCEHR may not be taking into account current developments in the Health IT arena overseas.
Call for e-Health scrutiny
Updated
West Australian doctors are calling for an independent body to review the Federal Government's planned e-Health system.
The call follows an international report which found while the United States government was spending billions of dollars in incentive payments to encourage doctors to adopt electronic health records, those records could in some instances threaten patient safety.
The Institute of Medicine in the US is now recommending an independent agency be set up to monitor health information technology.
The Australian Medical Association's David Mountain would like to see similar scrutiny of the e-Health system, which is expected to be in place by the middle of next year.
More here:
Second we have had the MSIA express some concerns regarding aspects of the safety associated with both the HI Service and some aspects of the proposed PCEHR.
See here:
Third we have had a lot of commentary emerge on the Institute of Management report.
The New York Times summarises the recommendations well:
November 8, 2011
Panel Emphasizes Safety in Digitization of Health Records
By STEVE LOHR
Poorly designed, hard-to-use computerized health records are a threat to patient safety, and an independent agency should be set up to investigate injuries and deaths linked to health information technology, according to a federal study released Tuesday.
The report by the Institute of Medicine comes as the government is spending billions of dollars in incentive payments to encourage doctors and hospitals to adopt electronic health records. The Department of Health and Human Services requested the study, in response to concerns from some doctors and public health experts that the drive for digital records might bring a wave of technology-induced medical errors.
The goal of moving from paper to computerized patient records is to improve patient care and curb health care costs. The federal report does not assert that the effort to move to electronic health records is misguided, but that safety considerations must be a crucial ingredient.
The proposed investigative agency, the report said, should be modeled after the National Transportation Safety Board, which examines airline safety and accidents. The Institute of Medicine committee also called for tracking the safety performance of electronic health records in use. Results from studies done so far, the report said, are mixed. Success stories are offset by reports of patients harmed.
The advisory group recommended that electronic health record suppliers drop “hold harmless” clauses from their sales contracts. Such language often limits the freedom of doctors and hospitals to publicly raise questions about software errors or defects.
More here:
Usefully the Office of the National Co-ordinator for Health IT in the US has already signalled a keenness to start work addressing the issues raised.
Mostashari assures patient safety plan sooner than 12 months
November 09, 2011 | Mary Mosquera
Dr. Farzad Mostashari, the national health IT coordinator, said that agencies in the Health and Human Services Department will work closely to craft a surveillance and action plan to keep patients safer through health IT, and it will be done sooner than called for by the Institute of Medicine.
An IOM report published this week directed ONC as the office that oversees health IT to complete its plan within 12 months.
“We appreciate the IOM’s recommendations in making sure that we really do have a coherent structure for reporting, analyzing and acting on the information about EHR-related safety incidents,” he said at the Nov. 9 meeting of the advisory Health IT Policy Committee.
He added that the committee will be an important part of bringing health IT stakeholders together for discussions about patient safety. The IOM calls for the freer flow of safety-related information and action by all stakeholders.
Mostashari said that the Office of the National Coordinator for Health IT will coordinate with the Food and Drug Administration (FDA), which regulates medical devices, and the Agency for Healthcare Research and Quality (AHRQ), which sponsors patient safety organizations, and the National Institute for Standards and Technology (NIST).
ONC has worked with AHRQ and FDA to promote reporting by EHR vendors on adverse events through patient safety organizations and with NIST to develop standards for EHR testing, measuring and usability.
In its report, IOM reaffirmed its faith in the potential for health IT to improve safety, Mostashari said. But it also made important recommendations to make sure that health IT’s potential is fully realized. The report becomes part of ONC’s long-term strategy for building in safety from the beginning as adoption of health IT moves forward, he said.
Safety is not just about reliable EHR system software product performance. Mostashari said that the report emphasized that “safety is a system.”
“Successful use of health IT means that we have to understand safety as part of the systematic approach. It means, system usability issues, having the right relationship between design of EHRs and the workflows,” he said.
In response to questions about whether FDA should be regulating EHRs as devices, Mostashari said that it was “clearly one of the most controversial issues that the committee struggled with.”
”My understanding of the report is that one of the key issues was the recognition that a broader set of issues needs to be addressed, not just the devices, but the entire system of how care is delivered, how training is done, and how workflows are done,” he said.
The report cites the need to balance the innovation agenda, and some of the concerns they expressed around the expertise needed for this may be different from device regulation in general, he said.
More here
To me the time for DoHA and NEHTA to come out and formally announce just what they plan in a policy and implementation sense in this area has now well and truly arrived.
It is just not good enough to have a Clinical Safety Unit beavering away (or apparently not) within NEHTA without some public indication of what they are doing, how it is being done and providing some evidence that what they are doing is actually working - not only for the PCEHR but for the e-Health domain as a whole.
We have been warned and NEHTA and DoHA need to respond properly to retain public trust and confidence.
David.
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