State HIE Sued for Alleged “Unauthorized” Use of PHI for Research

State HIE Sued for Alleged “Unauthorized” Use of PHI for Research

On January 3, 2025, a significant lawsuit was filed against a state HIE. The case was brought by a former employee and whistleblower who alleges that the HIE permitted unauthorized access and use of PHI for research purposes in violation of federal and state law, as well as operational policies. Although the facts that are currently known to the public are not sufficient to conclude whether or not HIPAA’s standards applicable to research were met, this case has the potential to influence not only the immediate parties involved but also broader interpretations of HIPAA compliance and enforcement in research settings. At a minimum, the case serves as a reminder that HIEs should be taking proactive steps to ensure that their internal policies, data use agreements, and HIPAA BAAs explicitly address research-related and similar activities in compliance with federal and state laws, including HIPAA.

read more
FDA issues COVID-19 Guidance for IRB Review of Expanded Access Requests; Updated Clinical Trial Conduct Considerations

FDA issues COVID-19 Guidance for IRB Review of Expanded Access Requests; Updated Clinical Trial Conduct Considerations

The FDA has issued guidance for IRB review of individual patient expanded access requests, as well as updated guidance for managing clinical trials during the COVID-19 public health emergency. Originally issued in March, the FDA’s updated “Guidance on Conduct of Clinical Trials of Medical Products...

read more

Archives