iHealth News is reporting today that a new Institute of Medicine report due out on Thursday will say that an entirely new regulatory agency is needed to oversee this largely unregulated sector, which can also injure or kill patients if it’s not operating properly. In pushing for a new oversight body, the respected Institute of Medicine, an independent research and advisory organization, is explicitly advising that the Food and Drug Administration (FDA) not be tasked with the job — a recommendation that is bound to be controversial.
The eagerly anticipated report, titled “Health IT and Patient Safety: Building Safer Systems for Better Care,” will be publicly released Thursday. The report details nine other recommendations for how to ensure patient safety when doctors and other health care providers use health information technology, or health IT. The findings from the report were presented October 28 to the Department of Health and Human Services (HHS) and its agencies.
Though a variety of studies have concluded that the use of health IT may improve patient safety, mistakes made in the systems or difficulty using the technology can lead to serious injury or death, according to the report. An allergy might be omitted from a computer record, for example, or an incorrect medication dosage might be recorded. In Rhode Island, a Lifespan computer glitch caused about 2,000 patients to receive the wrong types of medications. In another instance in March 2009, an unattended patient suffered multiple seizures for hours after a computer failed to alert doctors the patient was moved from the intensive care into their ward.
In its report, the IOM committee says the FDA would likely restrict market innovation in health IT, which could also jeopardize patient safety. Stringent regulations “can negatively impact the development of new technology by limiting implementation choices and restricting manufacturers’ flexibility to address complex issues,” the report says. The FDA currently receives voluntary reports of health IT-related incidents, but has no resources or protocols through which to take action; the agency has long fought a losing battle with health IT vendors over trying to monitor the technology.
The report also notes the agency does not have the investigative capabilities, funding or manpower to regulate devices such as electronic health records, personal health records or health information exchanges.
To adequately oversee health IT safety, the committee recommends that the secretary of health and human services create and fund a new independent watchdog agency, along the lines of the National Transportation Safety Board. Like NTSB, the new agency would conduct investigations and make recommendations for all stakeholders, including the secretary of the health and human services, vendors and health care organizations. Vendors of the technology would be required to report adverse events, while reporting would be voluntary for clinicians. Like NTSB, though, the new agency would also have no enforcement power.
The panel also recommends that the HHS secretary publically report on the progress of health IT safety each year, beginning in 2012. If the secretary determines at any time that adequate safety progress has not been made, only then should the FDA take the regulatory lead and be given the resources to do so, the report recommends, adding that the agency should be developing a framework now to be prepared.
The committee ruled out other agencies — including the Office of the National Coordinator, the Centers for Medicare & Medicaid Services and the Agency for Healthcare Research and Quality — as possible contenders for the position.
In its report, the IOM panel also recommended that another study be done to quantify health IT-related deaths, serious injuries or unsafe conditions so that the safety concerns can be properly addressed. “You can only improve what you measure,” says the report.
Other recommendations in the report: establishing and enforcing criteria for the safety of electronic health records, funding a new Health IT Safety Council to set standards for safety, and requiring all health IT vendors to publicly register and list their products with the Office of the National Coordinator. FMI go to http://www.iwatchnews.org/2011/11/07/7325/panel-recommends-new-agency-regulate-safety-health-information-technology/?utm_source=iwatchnews&utm_medium=site-features&utm_campaign=most-active
Tuesday, November 8, 2011
Friday, November 4, 2011
Designing better EHR's and PHR's
InformationWeek is reporting (Nov 4) that the National Institute of Standards (NIST), in conjunction with public and private sector stakeholders, has called on the healthcare community to help evaluate electronic health records (EHRs), examine the human factors that are crucial to their design, and assist with guidance on the development of usability engineering practices.
An October 27 webcast focused on NIST's recently released Technical Evaluation, Testing, and Validation of the Usability of Electronic Health Records, draft guidelines that review the rationale for an EHR usability protocol (EUP).
The guidelines outline procedures for expert evaluation of an EHR user interface from clinical and human factors best-practices perspectives. They also offer guidance on how to conduct validation studies of EHR user interfaces with representative user groups on realistic EHR tasks.
[For background on e-prescribing tools, see 6 E-Prescribing Vendors To Watch.]
"NIST's research and development is focusing on creating a specific methodology that will allow testers to objectively evaluate and measure usability in order to identify critical issues in the application, if any, prior to application deployment," Svetlana Lowry, NIST project lead for health IT usability, told InformationWeek Healthcare. "The most successful applications are products from vendors that can be easily and accurately used by providers. The NIST research and development goal is to support vendors in the development process by guiding them with best practices."
According to the draft guidelines document, there is consensus among many clinicians that EHRs could be simpler to use and that they can introduce user errors that could be harmful to patients. Furthermore, the ability to use EHRs with ease will encourage eligible hospitals and physician practices to adopt them, apply for reimbursements under the Medicare and Medicaid EHR incentive programs, and avoid penalties if they don't do so by 2015.
Emily Patterson, assistant professor at Ohio State University's college of medicine, noted during the webcast that research shows there are "critical use errors of electronic health records systems" that need to be addressed to help physicians and other clinicians mitigate mistakes when using EHRs.
Patterson said such errors can occur, for example, when accessing the wrong patient record, which can result in actions being performed for one patient that are intended for another. EHRs can also store incomplete information on a patient because of an inability to access and update the patient's notes from another provider. Additionally, there can be inadequate feedback, such as when a partial dose of medication in an inpatient setting is automatically converted to a higher dose of that medication when the patient is discharged from the hospital.
During the webinar, Dr. Chris Gibbons, associate director at Johns Hopkins Urban Health Institute, said aligning verbal documentation with EHRs can also cause difficulties in an inpatient care setting. "It's frequent that physicians give verbal orders; how those are handled within the EHR can be problematic," Gibbons said. He explained that workflow interruptions are likely to occur in a very busy clinical setting.
"While a provider is entering information many things could occur [including emergencies] that interrupt his input of that information into the electronic medical record. After a period of time has elapsed ... there could be timeout delays where after a certain period of inactivity all information previously entered is lost, which would then require the provider to start over," Gibbons observed.
To tackle these and related issues, the draft guidelines provide a three-step process for EHR design evaluation and human user performance testing that incorporates both the evaluation and validation procedures. The steps are as follows:
1. Usability/human factors analysis of the application during EHR user interface development,
2. Expert review/analysis of the EHR user interface after it is designed/developed, and
3. Testing of the EHR user interface with users.
The NIST health IT usability initiative is being conducted in collaboration with the office of the national coordinator for health IT (ONC) and the Agency for Healthcare Research and Quality (AHRQ). NIST has asked EHR vendors, health IT managers, and other health stakeholders to submit comments on the draft guidelines by November 10.
An October 27 webcast focused on NIST's recently released Technical Evaluation, Testing, and Validation of the Usability of Electronic Health Records, draft guidelines that review the rationale for an EHR usability protocol (EUP).
The guidelines outline procedures for expert evaluation of an EHR user interface from clinical and human factors best-practices perspectives. They also offer guidance on how to conduct validation studies of EHR user interfaces with representative user groups on realistic EHR tasks.
[For background on e-prescribing tools, see 6 E-Prescribing Vendors To Watch.]
"NIST's research and development is focusing on creating a specific methodology that will allow testers to objectively evaluate and measure usability in order to identify critical issues in the application, if any, prior to application deployment," Svetlana Lowry, NIST project lead for health IT usability, told InformationWeek Healthcare. "The most successful applications are products from vendors that can be easily and accurately used by providers. The NIST research and development goal is to support vendors in the development process by guiding them with best practices."
According to the draft guidelines document, there is consensus among many clinicians that EHRs could be simpler to use and that they can introduce user errors that could be harmful to patients. Furthermore, the ability to use EHRs with ease will encourage eligible hospitals and physician practices to adopt them, apply for reimbursements under the Medicare and Medicaid EHR incentive programs, and avoid penalties if they don't do so by 2015.
Emily Patterson, assistant professor at Ohio State University's college of medicine, noted during the webcast that research shows there are "critical use errors of electronic health records systems" that need to be addressed to help physicians and other clinicians mitigate mistakes when using EHRs.
Patterson said such errors can occur, for example, when accessing the wrong patient record, which can result in actions being performed for one patient that are intended for another. EHRs can also store incomplete information on a patient because of an inability to access and update the patient's notes from another provider. Additionally, there can be inadequate feedback, such as when a partial dose of medication in an inpatient setting is automatically converted to a higher dose of that medication when the patient is discharged from the hospital.
During the webinar, Dr. Chris Gibbons, associate director at Johns Hopkins Urban Health Institute, said aligning verbal documentation with EHRs can also cause difficulties in an inpatient care setting. "It's frequent that physicians give verbal orders; how those are handled within the EHR can be problematic," Gibbons said. He explained that workflow interruptions are likely to occur in a very busy clinical setting.
"While a provider is entering information many things could occur [including emergencies] that interrupt his input of that information into the electronic medical record. After a period of time has elapsed ... there could be timeout delays where after a certain period of inactivity all information previously entered is lost, which would then require the provider to start over," Gibbons observed.
To tackle these and related issues, the draft guidelines provide a three-step process for EHR design evaluation and human user performance testing that incorporates both the evaluation and validation procedures. The steps are as follows:
1. Usability/human factors analysis of the application during EHR user interface development,
2. Expert review/analysis of the EHR user interface after it is designed/developed, and
3. Testing of the EHR user interface with users.
The NIST health IT usability initiative is being conducted in collaboration with the office of the national coordinator for health IT (ONC) and the Agency for Healthcare Research and Quality (AHRQ). NIST has asked EHR vendors, health IT managers, and other health stakeholders to submit comments on the draft guidelines by November 10.
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