November 03, 2008
A Scholarly Review of EHR Regulation
In the first scholarly study on EHR regulation, faculty from Case Western University assess the need for federal regulation of electronic health record systems. The authors of this study point out that most Americans would argue against an increase in government regulation, but their research suggests that more regulation in an area like health care record systems is needed.
One of the authors, Sharona Hoffman, professor of law and bioethics at the School of Law, states that "we regulate drugs, transportation, communication, food, and many other goods and services, a safe and effective transition to computerized medical records cannot be achieved without federal regulation."
The study points out that electronic health records systems offer great promise to truly improve health care in the US and globally but "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."
The authors state that currently, the Certification Commission for Healthcare Information Technology (CCHIT), a private organization, conducts one-day testing of EHR systems. They believe that CCHIT's certification process is not sufficiently thorough and has several important shortcomings. It is suggested 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.
Another important factor that contributes to the future success of EHR systems is financial support.
* 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, the expense of purchasing and implementing EHR systems must be absorbed by health care providers.
* 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.
The authors describe that many of these problems can be solved through careful attention to system usability and user interface design. They suggest that federal regulations include a "best practices" standard and guidance as to how optimal usability is to be achieved. 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.
The goal of this study is the hope that it will reach policy-makers and be influential as the country continues to transition to EHR systems.
References/resources
"Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems" (Harvard Journal of Law and Technology, forthcoming 2009)
Source: American Association for the Advancement of Science Press Release
Posted by rsk at November 3, 2008 12:06 PM