sábado, 13 de marzo de 2010

FDA discusses oversight, regulation of HIT at ONC Workgroup hearing on patient safety.


FDA discusses oversight, regulation of HIT at ONC Workgroup hearing on patient safety.
Health IT Law & Industry Report; February 26, 2010.

This news article covers federal testimony in support of health information technology (HIT) system regulation by the United States Food and Drug Administration (FDA). The piece describes safety concerns that could result from HIT and discusses potential regulatory approaches to improvement, such as third-party reporting, confidentiality, and limited liability.

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http://healthcenter.bna.com/pic2/hc.nsf/id/BNAP-832S8W?OpenDocument

FDA Discusses Oversight, Regulation of HIT at ONC Workgroup Hearing on Patient Safety

A key medical device regulator from the Food and Drug Administration discussed a range of oversight and regulatory approaches that would categorize electronic health record systems as medical devices during a Feb. 25 informational hearing held by a workgroup of the Office of the National Coordinator for Health Information Technology's Policy Committee.

The certification and adoption workgroup heard from vendors, physicians, and government officials as to the impact EHR systems have had on patient safety.

According to Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, under the Federal Food, Drug, and Cosmetic Act, health information technology software is a medical device. However, “to date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices,” Shuren said.

Shuren stated that some HIT vendors have voluntarily registered and listed their software devices with FDA. In addition, patients, clinicians, and user facilities have been reporting HIT-related adverse events to FDA. Thus far, according to Shuren, FDA has received 260 reports of HIT-related malfunctions with the potential for patient harm, including 44 reported injuries and six deaths.

“Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist,” Shuren stated in written testimony.

Three Possible Approaches.
Shuren proposed three approaches for addressing safety concerns. The first approach would require HIT device manufacturers to electronically register and list their HIT devices, and to also submit medical device reports to the FDA. Under this approach, HIT device manufacturers would be responsible for correcting identified safety issues.

The second proposed approach would require HIT device manufacturers to comply with the same terms in the first approach, and also adhere to FDA's quality systems regulation, which requires manufacturers to comply with specific minimum guidelines to assure the “quality and consistency” of products on the market, Shuren said.

Under the third approach, the FDA would apply the traditional regulatory framework for medical devices to health IT software and systems, requiring vendors to meet the same regulatory provisions as traditional medical devices, including risk-based premarket review.

“The FDA recognizes the tremendous importance of HIT and its potential to improve patient care,” Shuren testified. “However, in light of the safety issues that have been reported to us, we believe that a framework of federal oversight of HIT needs to assure patient safety.”

Carl Dvorak, executive vice president of the software manufacturer Epic Systems, expressed in written testimony that regulation “will not necessarily create a safer EHR and might actually limit innovation and responsiveness when it is needed most.”

Complex Interactions.
Justin Starren, director of the Biomedical Informatics Research Center at the Marshfield Clinic, told the workgroup that most errors or failures of patient safety and electronic health records are a result of complex interactions: between human and computer, between one computer and another computer, or between humans.

Starren recommended that three critical factors need to be considered to address patient safety issues in health IT. The three factors are:

• third-party reporting performed by an organization other than the care provider organization or the software vendor;

• confidentiality for reporting so that organizations are more comfortable in disclosing the information; and

• limited liability protection.


In his written testimony, Starren warned that, “as a nation, we need to be very cautious about setting HIT standards that are too much of a stretch.”

Dvorak recommended that to address patient safety, it is important that clinicians are directly involved in the development process of the EHR, have real-time access to the EHR, that the EHR is easy to use, and that the software functions as intended.

Dvorak, along with Edward Shortliffe, president and chief information officer of the American Medical Informatics Association, also recommended that physicians, nurses, pharmacists, and any other users of health IT systems, should have a minimal amount of training in order to avoid potential mistakes.

Shortliffe also recommended that EHR assessments be completed after implementation. Starren agreed, adding that though a system may be certified before implementaion, many local configurations are applied to the system at each individual practice or hospital, and this could result in errors or software failures.

Attorney's Perspective.
The Feb. 25 testimony by FDA's Shuren comes on the heels of a letter sent Feb. 24 by Sen. Chuck Grassley (R-Iowa) to the Department of Health and Human Services, asking for answers about the regulation of HIT products and related patient safety concerns. Among the senator's questions for HHS were: Does the FDA “have sufficient authority to regulate HIT products, or is there a lack of clarity regarding the FDA's role?”

Bradley Merrill Thompson, an attorney with Epstein, Becker & Green, told BNA Feb. 25 that the FDA official's position on health IT being a regulated device “has enormous potential” impact on the industry. Based on the course the agency takes regarding such technology, the regulatory impact could be felt on the health IT software itself, and--due to connectivity--on the items used in tandem with the regulated product, he said.

Shuren's comments before the panel Feb. 25 will start a dialogue with industry, Thompson said, before any formal regulatory decisions are made. “This cannot be done quickly” due to the magnitude of the potential impact on industry, Thompson said.

Thompson noted that the FDA official's testimony before the health IT panel follows a late January FDA workshop on interoperability of medical devices.

By Genevieve Douglas


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Testimony from the hearing on patient safety is available at http://tinyurl.com/yex6x3l.

Text of the FDA official's Feb. 25 testimony is at
http://op.bna.com/hl.nsf/r?Open=bbrk-82zrmj.


Copyright 2010, The Bureau of National Affairs, Inc.

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