Federal Enforcement of Information Blocking Regulations Begins
Nearly a decade after the enactment of information blocking regulations under the 21st Century Cures Act, federal enforcement efforts are finally gaining momentum. The U.S. Department of Health and Human Services (HHS) is intensifying its focus on practices that impede access to, exchange of, and interoperability among electronic health information.
In an interview with Information Security Media Group, attorney Nan Halstead, a partner at Reed Smith, emphasized the importance for healthcare providers and certified health IT vendors to adopt best practices that comply with these regulations. She warned that failure to do so may expose organizations to investigations and potential penalties for information blocking.
The landscape surrounding enforcement is still evolving. Halstead noted that understanding what practices could trigger enforcement actions is complex and may vary as the regulatory framework becomes clearer. Although the specifics of enforcement actions have yet to fully materialize, it is expected that HHS will prioritize cases where information blocking adversely affects patient care or can lead to harm.
Halstead pointed out that many organizations might inadvertently engage in information blocking without being fully aware of it. This underscores the necessity for leaders in the healthcare sector to remain diligent and proactive in their compliance efforts.
During her discussion, Halstead outlined specific categories of practices that are likely to draw increased scrutiny from HHS. She also elaborated on the privacy and security exceptions related to information blocking, helping organizations navigate these critical aspects of compliance. Furthermore, she offered strategic advice on how to avoid potential violations of the information blocking regulations.
At Reed Smith, Halstead specializes in guiding a diverse range of clients, including medical device manufacturers, diagnostic testing facilities, telehealth providers, and electronic health record companies. Her expertise extends to compliance issues surrounding fraud, privacy, and reimbursement, as well as advising on HIPAA and the intricacies of health information interoperability.
The evolving regulatory environment mandates that healthcare providers and related organizations prioritize compliance to avert enforcement actions. As discussions around information blocking gather momentum, stakeholders are encouraged to align their operational practices with the legal expectations, ensuring that they remain focused on enhancing patient care while also mitigating potential risks related to data privacy and access.
In summary, the landscape of information blocking regulation is shifting, with a clear signal from HHS regarding its intent to enforce compliance. Organizations must adapt swiftly to navigate this new era of accountability in healthcare data exchange, maintaining diligence in their practices to avert potential penalties and serve their patients effectively.
