Electronic health records

Information technology is changing health care. Federal regulators are looking to draft rules to protect patient safety in this new landscape.

The Food and Drug Administration is trying to draw up a framework for the FDA, the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology to regulate information technology related to medical devices, electronic health records, and other health IT, the Washington Post reports.

The recent report on the plan is out for public comment and "signals that the FDA might pursue a loose regulatory framework for some elements of health-care IT, allowing technologists to innovate without being burdened by federal oversight, said Gartner analyst Wes Rishel," the Post further reports.

Electronic health records are being adopted by health care providers at an increasing pace, including due to incentives from the federal government. But "modern EHRs are often overly focused on data entry and typically provide poorly designed data displays with rudimentary functions for searching and organizing patient data. The data entry steals physician time away from direct patient care," Forbes reports. The Government Accountability Office has said the incentive program for EHRs doesn't have the ability to demonstrate that patient care is improved by EHRs, Forbes also reports.

The electronic health records industry is "gearing up for a Washington lobbying fight against federal safety regulations," the Boston Globe reports. The Obama administration is going to release plans in the coming months on how information technology in the health industry should be regulated. The issue is "whether the systems should be considered medical devices and, therefore, regulated by the Food and Drug Administration just as a cardiac stent or a pacemaker is regulated," the Globe also reports.

Some say that electronic health records, also known as digital medical records, can lead to prescribing errors or other errors in patient care that harm patients, the Globe further reports.

Medical Economics reports that Health Insurance Portability and Accountability Act (HIPAA) is hindering the ability of healthcare providers to coordinate care, including with patients who want family and friends to have access to their health records: "According to a report in the January 22/29 Journal of the American Medical Association (JAMA), privacy and security regulations aren’t keeping up with the convergence of technology and an increased emphasis on care coordination." 

The Inspector General of the U.S. Department of Health & Human Services has issued final safe-harbor regulations for payments and business practices related to electronic health records. Some of these payments and practices would otherwise implicate the federal anti-kickback statute. EHR Intelligence reports that federal regulators have extended the safe harbor until Dec. 31, 2021, with three goals: to incentivize the adoption of EHRs, align the date on which the safe harbor will sunset along with the ending of incentives for the meaningful use of such EHRs, and to provide protection against “'foreseeable future fraud risks.'”

FierceEMR reports that consolidation and new business relationships between healthcare providers will create issues regarding patient privacy and electronic health records, according to two healthcare attorneys interviewed by the blog.

Health law attorneys Michael Kline and Elizabeth Litten with Fox Rothschild in Princeton, N.J., told FierceEMR that the issues could include:

a. the expansion of health care entities "increases the risk of breach of the data as the octupus grows";

b. fights over who gets the patient, including if it means that the entity that controls the health care records is in control of the patient.

Science 2.0 has a blog about a study done at the University of Utah on attitudes toward sharing personal health information. The researchers found that when study subjects were educated about "the intricacies involved in collecting and using this information in population-based research—particularly the safeguards and confidentiality measures in place to maintain anonymity—that they support it," Science 2.0 reports. This finding comes despite the lack of privacy some feel because of "the Obama administration ... using surveillance cameras, tracking website visits and monitoring citizens using GPS," the blog says.

An audit by the Department of the Health and Human Services' Office of Inspector General found that most hospitals don't have policies about copying and pasting health information in electronic health records, iHealthBeat reports. That could lead to health care fraud and abuse such as fraudulent billing and incorrect information being entered into patient records. Only 24% of hospitals had a policy regarding the "improper use of copy-and-paste functions within EHR systems," iHealthBeat further reports.

Separately, Government Health IT reports that earlier this month the Centers for Medicare & Medicaid Services decided to propose a delay in the next two stages of its program to incentivize healthcare providers to adopt "meaningful use" of electronic health records in exchange for governmental incentives.

The Concord Monitor reports that the "federal stimulus bill passed in 2008 contained billions of dollars in funding for medical providers to adopt electronic health records." The carrot: the financial incentives to adopt electronic health records. The stick: if healthcare providers do not achieve "meaningful use" in their electronic records, they face deductions from their Medicare payments.

However, some independent physician practices that do not have a lot of Medicare payments find "the incentives haven’t been big enough to justify the costs of meeting the high standards," The Monitor further reports.

Doctors find some benefits from electronic records but they also find the records to be "cumbersome, time-consuming and annoying" than old-fashioned paper charting, The Monitor further reports.

The value of electronic health records will likely improve if healthcare providers become more agile in using them and if the systems also are redesigned and updated to reflect the deficits many users find in them.

Legislation introduced in the U.S. Senate (and which mirrors legislation introduced in the House of Representatives) would expand the federal incentives for the adoption of electronic health records to "psychiatric hospitals, substance abuse facilities and psychologists," according to FierceEMR. Senator Rob Portman, R-Ohio's bill also would ensure that electronic health records are not medical devices to be regulated under the Food, Drugs and Cosmetics Act and limit electronic discovery of electronic health records, the web site also reported.