In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device...more
In this episode, Health Care partner Rebecca Schaefer interviews Karishma Page, partner of the firm’s Public Policy and Law practice group, on what is likely to be coming down the pike in the health care policy landscape of...more
2/18/2021
/ Biden Administration ,
Coronavirus/COVID-19 ,
Executive Orders ,
Federal Funding ,
Health Care Providers ,
Hospitals ,
Legislative Agendas ,
Medical Centers ,
Physicians ,
Regulatory Agenda ,
Relief Measures ,
Research Funding ,
Rulemaking Process
In this week’s episode, Rebecca Schaefer and Hannah Maroney discuss a string of recent HIPAA enforcement actions which demonstrate that the HHS Office of Civil Rights (OCR), the agency tasked with enforcing HIPAA, is...more
8/20/2020
/ Business Associates ,
Business Associates Agreement (BAA) ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Encryption ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
HIPAA Privacy Rule ,
HIPAA Security Rule ,
Hospitals ,
OCR ,
Parent Corporation ,
PHI ,
Policies and Procedures ,
Settlement Agreements ,
Third-Party Service Provider
Hospitals and health systems play a central role in helping to address the opioid crisis. Even before increased national attention, hospitals were developing policies, protocols, and procedures for opioid prescribing best...more