Healthcare privacy laws in the United States are due an update to bring them into the modern age to ensure individually identifiable health information is protected no matter how it is collected and shared. The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is now more than 2 decades old, and while the Department of Health and Human Services (HHS) has proposed updates to the HIPAA Privacy Rule that are due to be finalized this year, even if the proposed HIPAA Privacy Rule changes are signed into law, there will still be regulatory gaps that place health data at risk.
The use of technology for healthcare and health information has grown in a way that could not be envisaged when the Privacy Rule was signed into law. Health information is now being collected by health apps and other technologies, and individuals’ sensitive health information is being shared with and sold by technology companies. The HIPAA Privacy and Security Rules introduced requirements to ensure the privacy and security of health data, but HIPAA only applies to HIPAA-covered entities – healthcare providers, health plans, and healthcare clearinghouses – and their business associates. Some of the emerging technologies now being used to record, store, and transmit health data are not covered by HIPAA and its protections and safeguards do not apply. Further, the proposed updates to the HIPAA Privacy Rule will make it easier for individuals to access their health data and direct covered entities to send that information to unregulated personal health applications.
New bipartisan legislation has now been introduced that aims to start the process of identifying and closing the current privacy gaps associated with emerging technologies to ensure health data are better protected, including health data that are not currently protected by HIPAA. The Health Data Use and Privacy Commission Act was introduced by Sens. Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) and aims to set up a new commission that will be tasked with analyzing current federal and state laws covering health data privacy and make recommendations for improvements to cover the current technology landscape.
“As a doctor, the potential of new technology to improve patient care seems limitless. But Americans must be able to trust that their personal health data is protected if this technology can meet its full potential,” said Dr. Cassidy. “HIPAA must be updated for the modern day. This legislation starts this process on a pathway to make sure it is done right.”
The Comptroller General is tasked with appointing committee members who will be required to submit their report, conclusions, and recommendations to Congress and the President within 6 months. The commission will be required to assess current privacy laws and determine their effectiveness and limitations, any potential threats to individual health privacy and legitimate business and policy interests, and the purposes for which the sharing of health data is appropriate and beneficial to consumers.
The commission is required to report on whether further federal legislation is necessary and, if current privacy laws need to be updated, provide suggestions on the best ways to reform, streamline, harmonize, unify, or augment current laws and regulations relating to individual health privacy. Those recommendations could involve updates to HIPAA to cover a broader range of entities or new state or federal legislation covering health data. If updates are recommended, the commission will be required to provide details of the likely costs, burdens, and potential unintended consequences, and whether there is a threat to health outcomes if privacy rules are too stringent.
“I am excited to introduce the bipartisan Health Data Use and Privacy Commission Act to help inform how we can modernize health care privacy laws and regulations to give Americans peace of mind that their personal health information is safe, while ensuring that we have the tools we need to advance high-quality care.”
The Health Data Use and Privacy Commission Act has attracted support from a dozen medical associations and technology vendors, including the Federation of American Hospitals, College of Cardiology, National Multiple Sclerosis Society, Association of Clinical Research Organizations, Epic Systems, and IBM.
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