CWRU Professors Call for Regulation of Electronic Health Records

November 3, 2008 // Published as a news service by IHS

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"Electronic information can be illicitly accessed from anywhere and transmitted across the globe quickly, cheaply and with little risk of detection," said Sharona Hoffman, professor of law and bioethics at the School of Law.

"EHR systems could transform health care in the U.S., but their potential will be realized only with careful oversight," she said.

Hoffman, along with her husband, Professor Andy Podgurski from the Case School of Engineering, are responsible for one of the first scholarly studies to assess the need for federal regulation of EHR systems.

Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems (Harvard Journal of Law and Technology, forthcoming 2009) comes on the heels of two previous publications by the two on security and privacy issues of EHRs and critiques of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule.

Most Americans would argue against an increase in government regulation, but as Hoffman believes, some regulation in an area like health care record systems is needed.

"We regulate drugs, transportation, communication, food and many other goods and services," she said. "A safe and effective transition to computerized medical records cannot be achieved without federal regulation."

The pair said they realized the implications of EHR systems for both law and computer science and the need for further study in a discussion over dinner. Additional conversations led to their joint research agenda and regulatory framework. They hope their work will reach policy-makers and be influential as the country continues to transition to EHR systems.

"Electronic health records systems offer great promise for significantly improving health care in the U.S. and around the world," said Hoffman.

"However, their complexities generate many risks of software and hardware failures and adverse patient outcomes, and thus they require rigorous regulation. This is an exciting time for health information technology, but it must be approached cautiously and thoughtfully."

Currently the Certification Commission for Healthcare Information Technology (CCHIT) conducts one-day testing of EHR systems. Hoffman and Podgurski, however, believe that the CCHIT certification process is not sufficiently thorough and has several shortcomings.

The professors suggest that CCHIT oversight be replaced by governmental oversight and that an extensive testing and approval process be established. Without this testing, new EHR systems should not be marketed, just as drugs and devices cannot be sold if they have not been approved by the Food and Drug Administration (FDA).

In addition, EHR systems must be subject to monitoring throughout their operational lifetimes to ensure that technical problems are detected and resolved.

When asked who should be responsible for this regulation Hoffman replied, "Some may think the FDA is the natural choice. However, the FDA is currently a beleaguered agency, which is heavily criticized and plagued by insufficient resources. In addition, the clinical trial model that is used for drug and device approval is not a good fit for EHR systems."

Instead, the researchers suggest regulation by the Centers for Medicare & Medicaid Services, which already enforce the HIPAA Security Rule, or a newly created agency with jurisdiction over health information technology.

Financial support and incentives are also critical to the success of the transition to EHR systems.

• It is estimated that the cost of purchasing an EHR system is $33,000 for each physician, with an additional cost of $1,500 per doctor per month for maintenance. This expense has cost challenges for many providers, especially those in small practices. Some estimate that the long-term cost savings produced by a national health information network could reach $77.8 billion a year from a reduction in medical errors, diagnostic test duplication and administrative expenses.

• Currently, however, only 17% of physicians in ambulatory care settings use them to any extent, and only 11% of hospitals have fully implemented them. The slow pace of EHR system adoption may reflect a misalignment of incentives. While cost savings will be enjoyed primarily by insurers and the government, health care providers must absorb the expense of purchasing and implementing EHR systems.

• Several congressional bills, including the Health Information Technology Act of 2007 and the Wired for Health Care Quality Act of 2007, were designed to provide financial incentives such as tax credits and grants but have not passed due to other health care priorities.

• Some clinicians may resist computerization for more than just monetary reasons. There is concern that patients may suffer from less face-to-face time with their physicians if it becomes more time consuming for doctors to input information into a computer than it is to dictate notes. Others believe that EHR systems require time-consuming documentation of irrelevant facts, are difficult to navigate and do not organize clinical information in a way that enhances the delivery of treatment.

Hoffman and Podgurski said many of these problems can be solved through attention to system usability and user interface design. They suggest that federal regulations include a best practices standard and guidance as to how to achieve optimal usability.

They also emphasize the importance of interoperability, which will allow EHRs to be transmitted electronically from one provider to another so that work does not have to be duplicated each time a patient sees a new clinician.

Source: Case Western Reserve University.