The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule does not adequately protect the privacy of people's personal health information and hinders important health research discoveries, concludes a new report from the Institute of Medicine.
Congress should authorize the development of an entirely new approach to protecting personal health information in research, separate from the HIPAA Privacy Rule, said the committee that wrote the report. This new approach should apply privacy, data security, and accountability standards uniformly to information used in all health-related research regardless of who funds or conducts the research.
If policymakers decide to continue relying on the current rule to protect privacy in health research, the committee recommends a series of changes to improve the rule and the guidance that the U.S. Department of Health and Human Services (HHS) gives on how to comply with it.
In addition, the report urges all institutions conducting health research to strengthen their data protection. Security breaches are a growing problem for health information databases. Among the measures that should be taken, encryption should be required for all laptops, flash drives, and other portable media containing such data given the potential for these items to be lost or stolen.
The committee's recommendations recognize the valuable societal benefits that both ethically conducted health research and privacy protections provide. Without such research, society would lose the benefit of new therapies, improved diagnostics, and more effective ways to prevent illness and deliver care. Privacy helps protect individuals from harm, such as discrimination and identity theft, and permits research and public health activities to be carried out in ways that preserve their dignity.
"We believe there is synergy between the goals of safeguarding privacy and enhancing health research and that it is critically important to our nation's health to strengthen privacy protections and still facilitate research," said committee chair Lawrence O. Gostin, professor of law and director, O'Neill Institute for National and Global Health Law, Georgetown University Law Center, Washington, D.C. "Our recommendations aim to boost regulations and practices that effectively protect personally identifiable health information, while changing provisions of the HIPAA Privacy Rule or its interpretations that have proved to be ineffective."
The HIPAA Privacy Rule regulates what uses and disclosures of personally identifiable health information are permitted by health plans, health care providers, and other entities covered by the regulation. The goal is to ensure that individuals' health information is properly protected while allowing the flow of data needed to promote high-quality health care and health-related research.