Information Blocking in Healthcare: Legal and Regulatory Issues
February 25, 2025
Healthcare in the United States relies heavily on the exchange of electronic health information (EHI). The 21st Century Cures Act, passed by Congress in 2016, aimed to promote medical research, drug development, and the digitization of EHI. This act also introduced regulations to prevent information blocking, which is any practice by healthcare providers or technology firms that interferes with or discourages the access, exchange, and use of EHI.
Recently, a podcast on the American Bar Association’s Our Curious Amalgam explored potential competition law issues related to information blocking. The podcast featured Jeny Maier, Managing Partner at Axinn, Veltrop & Harkrider, and Matt Tabas, Antitrust & Competition Partner at Arnold & Porter, along with guest speaker David B. Schwartz, a partner in Bryan Cave Leighton Paisner’s Antitrust & Competition Practice Group.
The Cures Act envisioned digital health records as the norm, with the expectation that taxpayers would benefit from the convenience of EHI, and that innovation in health technology would improve healthcare. To achieve these goals, the Act prohibited information blocking, rooted in competition-law principles, to address concerns about a potential “refusal to deal.” Congress was worried that a firm in this space might hinder a rival’s ability to compete by refusing to sell or provide access to EHI as an essential input or service.
The Department of Health and Human Services (HHS), the agency charged with implementing the Cures Act, collaborated with the Federal Trade Commission (FTC) in defining the regulatory parameters. This collaboration built on the FTC’s prior work in this area, including a 2014 public workshop, and a 2015 report on information blocking to Congress. For example, the Cures Act requires the holder of EHI to license the IP on fair and non-discriminatory terms, a requirement that mirrors the “FRAND” obligation under antitrust law, which requires the holder of a standard-essential patent to license the patent on fair, reasonable, and non-discriminatory terms.
The Real Time v. PCC Lawsuit
While the Cures Act was passed in 2016, it wasn’t until January 2024 that the first lawsuit alleging violations of the information-blocking ban was filed. Real Time Medical Systems (“Real Time”), a healthcare data analytics company, brought a case against PointClickCare Technologies (“PCC”). Real Time analyzes electronic health records to identify health issues that caregivers might miss while PCC is a records storage platform used to access the underlying EHR.
Real Time alleges that PCC engaged in information blocking by denying Real Time access to EHI and using CAPTCHA walls to prevent access. Real Time claims PCC denied access because PCC has a software product that competes with Real Time. The U.S. District Court for the District of Maryland granted Real Time’s motion for a preliminary injunction, and the case is currently under interlocutory appeal before the Fourth Circuit.
The Our Curious Amalgam podcast offered a valuable introduction to the issues and raised critical questions. The podcast discussed the potential outcomes of the Fourth Circuit’s appeal and the future direction of the Real Time v. PCC case. Additionally, the podcast examined the future of public and private enforcement regarding the Cures Act’s information blocking rules and how HHS’s approach to this area might change.
