EMR certification proposal outlines path to "meaningful use"

Concerns about safety issues from health IT malfunctions could result in more federal oversight.

By Chris Silva — Posted March 15, 2010

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The federal government has unveiled a two-phase process for certifying the electronic medical records systems physicians must adopt if they hope to collect Medicare and Medicaid EMR incentives.

On March 2, the Health and Human Services Dept. released a proposed rule outlining how it will roll out an EMR certification program to identify vendors and products that will allow doctors and hospitals to meet the government's "meaningful use" standards.

The first phase would create a temporary certification process under which David Blumenthal, MD, the national health information technology coordinator, would authorize organizations to test EMR modules and give them a federal stamp of approval. The temporary phase would ensure the availability of certified technology before next year, when physicians can start becoming eligible for an estimated $14.1 billion to $27.3 billion in net Medicare and Medicaid incentives made available through the most recent federal stimulus package.

The second phase would replace the temporary certification program with a permanent one that establishes an outside agency to accredit certification bodies under expanded rules. HHS plans to make that change by the first quarter of 2012. The second phase also would permit certification bodies to certify other types of information systems besides EMRs.

An interim final rule released in December 2009 outlined the certification standards that entities initially would use to approve EMRs, but it did not identify who those certification bodies would be or how they would be accredited. Organizations can start applying to become certification bodies after the newest proposed rule is finalized later this year.

Dr. Blumenthal said the plan should provide the health care community with assurances that the EMR technology they purchase has what it takes to help them meet meaningful use standards. "While we are making significant strides towards modernizing our health care system, these efforts will only succeed if providers and patients are confident that their health information systems are safe and functional."

Once the rule is finalized, the Certification Commission for Health Information Technology will apply to be one of the groups approved by Dr. Blumenthal to start certifying EMRs under the temporary program, said Alisa Ray, CCHIT's executive director. "We feel confident about the future, and we look forward to the opportunity to continue playing a role in accelerating the adoption of health IT."

CCHIT was founded in 2004 and has been certifying EMRs since 2006.

It is the only certifying body so far that has been recognized by the federal government.

Going paperless safely

Concerns about the safety of EMRs have been receiving more attention at the federal level recently, with some warning that the government might need to make regulatory changes to ensure that safety lapses do not result from a rush to adopt the technology.

At a Feb. 25 hearing before the Health Information Technology Policy Committee, a Food and Drug Administration official testified that in the past two years, his office has received 260 reports of health IT-related malfunctions with potential for patient harm -- including 44 reported injuries and 6 reported deaths. Because such reports are voluntary, they may represent only the tip of the iceberg in terms of safety problems that might exist with the technology, the official said.

"The FDA recognizes the tremendous importance of HIT and its potential to improve patient care," said Jeff Shuren, director of the agency's Center for Devices and Radiological Health. "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."

The FDA requires that manufacturers of software devices comply with the laws and regulations that apply to more traditional medical device firms. But to date, the agency has largely refrained from enforcing regulatory requirements with respect to EMRs and other information technology, Shuren said.

Shuren said the FDA could focus more on postmarket safety by requiring vendors to register their systems electronically and submit medical device reports to the agency. Based on the data generated, the FDA then could recommend design controls that would mitigate risks unique to the systems, he said.

The issue has generated some attention from lawmakers. Sen. Charles Grassley (R, Iowa), the ranking GOP member on the Senate Finance Committee, sent a letter on Feb. 24 to HHS Secretary Kathleen Sebelius asking what the department is doing to ensure that patient safety concerns are being monitored, and what role the FDA plays in health IT regulation.

But some industry experts said increased FDA regulation would just convolute the process and cause greater confusion among physicians, hospitals, vendors and certifiers.

"I really think it adds a greater complexity, and what I'm not clear on is how FDA oversight would differ from the certification process," said Bruce Taffel, MD. He's vice president and chief medical officer for SharedHealth, a vendor of health information products and solutions based in Chattanooga, Tenn. "I'm not sure what would happen to certification if the FDA is given more authority in this area."

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Certifiers also have standards to meet

For doctors and hospitals to receive timely federal EMR incentive payments, certified technology must be made available before the fall of 2010. The Office of the National Coordinator for Health Information Technology says that for certification bodies to be approved to green-light EMR systems, they must:

  • Maintain their accreditation.
  • Attend all mandatory ONC training and program update sessions.
  • Maintain a training program to ensure that their personnel are competent to certify EMRs.
  • Report to ONC within 15 days any changes that materially affect policies, procedures, personnel, organization, management, location, working environment or facilities.
  • Allow ONC and its authorized agents periodically to observe on site any certifications performed.
  • Provide to ONC, no less frequently than weekly, a current list of EMRs that have been certified, including the vendor name, date certified, product version and unique certification number.
  • Retain all records related to the certification of EMRs for a minimum of five years.
  • Submit an annual surveillance plan to ONC and annually report results.

Source: Proposed Establishment of Certification Programs for Health Information Technology, Dept. of Health and Human Services, March 3 (link)

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