HHS to Issue New Rules to Shield Patients’ Medical Records
The Clinton administration will issue "broad" new regulations Dec. 20 to protect patients' medical records, establishing the first federal laws that prevent doctors, hospitals and health plans from releasing such information without patient consent, the Washington Post reports. The rules, "significantly more far reaching" than the regulations proposed by HHS last year, will take full effect within two years. Under the regulations, providers must obtain written consent from patients for even "routine disclosure" of electronic records, as well as paper records and oral communications -- closing a "loophole" in the initial proposed regulations that would have allowed large self-insured employers to access medical records without patient approval (Eilperin, Washington Post, 12/20). In addition, patients will have a "federal right" to access and copy their medical records and to request "correction" of information that they consider "inaccurate or incomplete" (Pear, New York Times, 12/20). The regulations also establish new civil and criminal penalties for health care providers and insurers that "improperly use or disclose" medical information, including a $50,000 fine and a year in prison for intentional disclosure and up to a $250,000 fine and as many as 10 years in prison for disclosure with the intent to sell (Washington Post, 12/20). "We think we've struck the right balance," Melissa Skolfield, a spokesperson for HHS Secretary Donna Shalala, said, adding, "We've tried to give patients the broadest protections we could while still creating a system that's logical and understandable" (Appleby, USA Today, 12/20). White House health policy advisor Chris Jennings added, "The new rules will apply to all health insurers and virtually every health care provider ... and [they] will give patients more control over and access to their medical records" (Rubin, Los Angeles Times, 12/20). According to Jennings, President Clinton will unveil the new rules today at HHS.
'Major Victory' for Patients
Patient advocates applauded the new rules as a "major victory for consumers" (New York Times, 12/20). "At a time when consumers are demanding online access to their physicians and to their medical information, the new privacy law will help drive necessary changes in how this information is protected," California HealthCare Foundation CIO Sam Karp said (CHCF release, 12/20). According to Janlori Goldman, director of the Health Privacy Project at Georgetown University, "It's the most sweeping privacy law ever in U.S. history, and it will have a major impact on the entire health care field." Ron Weich of the American Civil Liberties Union added, "Medical information is the most intimate information people have, and it's important that the individual control that information." Still, he said that the rules do not "directly" cover pharmaceutical companies and businesses that process medical claims or prevent police from accessing patient records (Washington Post, 12/20). "In general, the new rules are a step forward, but they have a loophole. They allow the police to gain access to medical records without having a judge view the justification." In addition, the rules do not allow patients to sue providers for releasing their medical records (New York Times, 12/20).
'Onerous, Costly' for the Industry?
The new rules have also stirred "controversy" among hospitals, insurers and HMOs, which argue that the restrictions will "boost costs and hamper research" (Washington Post, 12/20). Kristin Stewart of the American Association of Health Plans, said, "Many of our members already have their own confidentiality policies in place. I think it's too early to say if our members will be able to live with these rules" (USA Today, 12/20). According to Suzanne Charleston, head of government affairs for the Pharmaceutical Care Management Association, "There's a lot of concerns within the industry that [the rules] may be overly burdensome and cost prohibitive for us to meet" (Washington Post, 12/20). Industry officials also contend that restrictions allowing them to release only the "minimum necessary" patient information and forcing health plans and providers to require their affiliates to follow the same rules may prove "[p]articularly troublesome." Melinda Hatton, an attorney with the American Hospital Association, said, "[W]hat's been frustrating is that (the administration has) not appreciated the profound cost impacts of this rule" (Los Angeles Times, 12/20). Calling the rules "onerous, costly requirements," Health Insurance Association of America President Chip Kahn said, "Insurers and health plans feel strongly that consumers' records should be protected. However, these rules give us no uniformity" (New York Times, 12/20). The White House estimates that the patient privacy regulations could cost the health care industry about $17.6 billion over 10 years, but points out that rules issued earlier this year to "streamline billing procedures" would save the industry $29.9 billion and "offset" the expenses (USA Today, 12/20). In addition to cost concerns, health plan officials argue that the "vague" rules could open them to liability under more stringent state laws (McGinley, Wall Street Journal, 12/20).
Final Word from Bush?
While President-elect Bush may attempt to revise the rules, he has not "expressed any reservations" about the patient privacy regulations. Gail Wilensky, a Bush health care policy adviser, said, "[T]he new administration will probably want to review the details of these standards -- the benefits, costs and burdens -- as with any rules issued late in President Clinton's term" (New York Times, 12/20). To revise the rules, the Bush administration would have to "show cause" and allow a "round of public comment" before taking formal action. However, a White House official called the action "unlikely," noting, "We would be very surprised if [Bush] did that" (Washington Post, 12/20). Congress could also overturn the rules, but experts predict that passing such legislation remains "unlikely" (AP/Washington Times, 12/20).