Although information blocking regulations were authorized under the 21st Century Cures Act nearly a decade ago, federal regulators are only starting to ramp up enforcement of the prohibition against practices that hinder the access, exchange, use or interoperability of electronic health information.
Attorney Nan Halstead, a partner of the law firm Reed Smith, advises healthcare providers, certified health IT vendors, health information exchange and other organizations subject to the regulations to take a number of critical steps in avoiding practices that could potentially be deemed “information blocking” and subject to investigations and enforcement penalties by the U.S. Department of Health and Human Services.
“This is not going away. Regulated actors should align their practices with the regulation – and that’s easier said than done,” Halstead said in an interview with Information Security Media Group.
“It’s been a long road to figure out what enforcement’s going to look like for regulated actors, and I think it’s going to be an even longer road to understand exactly what practices are going to yield enforcement because we haven’t seen any yet.”
But HHS will likely focus on several investigative and enforcement priorities including information blocking practices that could negatively affect patient care or cause harm, she said.
“I think certain companies can inadvertently engage in information blocking” without realizing it, she said.
In this audio interview with Information Security Media Group (see audio link below photo), Halstead also discussed:
- The types of information blocking practices that HHS is mostly likely to crack down on;
- What to know about privacy and security exceptions to information blocking;
- Tips to avoid committing potential information blocking violations.
Halstead is a partner at Reed Smith, where she advises medical device manufacturers, independent diagnostic testing facilities, telehealth providers, electronic health record companies and other health technology providers on compliance issues related to fraud and abuse, privacy and reimbursement. She helps clients with strategic data partnerships and commercial strategies for mobile health applications and connected devices, and advises companies on HIPAA, health information privacy, interoperability issues and compliance with federal Interoperability, information blocking and patient access rules.
