On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more
In this episode, Rebecca Schaefer and Martin Folliard discuss cybersecurity threats faced by health care organizations and a new federal research agency initiative to help create security tools to protect the US health care...more
In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more
6/1/2023
/ Biologics ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Centers ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Comment ,
Regulatory Requirements ,
Scientific Research
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
On 25 August 2022, the Office of Science and Technology Policy (OSTP) released a guidance memorandum instructing federal agencies with research and development expenditures to update their public access policies. Notably,...more
In this episode, Rebecca Schaefer and J.D. Koesters review key components of the recent National Institute of Standards and Technology (NIST) revised publication regarding cybersecurity. They highlight how this resource...more
In this episode, Rebecca Schaefer and Gina Bertolini discuss the incredible value of health care data and how providers can harness the power of data transactions to drive innovation, discovery, and advancements in medical...more
In this episode, Rebecca Schaefer interviews Gina Bertolini and Desiree Moore about the recent Federal Trade Commission (FTC) policy statement regarding the FTC Health Breach Notification Rule and its applicability to vendors...more
10/7/2021
/ Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Records ,
Mobile Health Apps ,
PHI ,
Policy Statement ,
Vendors
Colleges, universities, and their federally funded research centers must navigate a range of evolving legal challenges associated with changing technologies, increased frequency of cyberattacks, global expansions, and more....more
In this week’s episode, Richard Church interviews Rebecca Schaefer about the intersection and blurred line between clinical research and quality initiatives. The presenters discuss what factors to consider when defining...more
I. INTRODUCTION - On 8 June 2021, the Senate passed an expansive bipartisan bill aimed at enhancing the country’s scientific research and development capabilities. In response to emerging technological competition from...more
On 9 April 2021, during a weekly economic briefing, President Biden announced his administration’s intent to establish and fund a new regulatory agency, named the Advanced Research Projects Agency for Health (ARPA-H), which...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
INTRODUCTION - On 10 December 2020, the Office of Civil Rights (OCR) for the federal Department of Health and Human Services (the Department) issued Proposed Modifications to the HIPAA Privacy Rule to Support, and Remove...more
In this episode, Rebecca Schaefer and Victoria Hamscho discuss the impact of the ongoing COVID-19 pandemic on university research programs and public policy projections for a potential federal response. The presenters are...more
11/23/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Educational Institutions ,
Health and Safety ,
Infectious Diseases ,
Medical Research ,
Public Policy ,
Relief Measures ,
Remote Working ,
Research and Development ,
Universities
On 29 October 2020, the National Institutes of Health (NIH) issued its final NIH Policy for Data Management and Sharing (the DMS Policy), which updates and replaces the 2003 NIH Data Sharing Policy. Although the DMS Policy...more
In this episode, Rebecca Schaefer and Victoria Hamscho provide an update on next month’s Supreme Court oral arguments in California v. Texas, a case in which the Court will be reviewing the constitutionality of key parts of...more
10/29/2020
/ Affordable Care Act ,
California v Texas ,
Constitutional Challenges ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
Individual Mandate ,
Oral Argument ,
Presidential Elections ,
Repeal ,
Tax Penalties
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
In the context of a rapidly evolving health care industry, there is a growing trend for health systems to establish and experiment with their own captive venture capital investment funds as an adjunct to more traditional...more
INTRODUCTION - The U.S. Department of Health and Human Services (HHS) and its operating and staff divisions (HHS Divisions) have granted an unprecedented amount of regulatory flexibility to aid health care providers in their...more
As the COVID-19 pandemic continues to put unprecedented strain on health care providers across the country, the federal government is establishing various programs to provide them immediate support. To this end, the Federal...more
INTRODUCTION - The COVID-19 outbreak has placed an unprecedented burden on the global health care community and caused significant disruption to numerous aspects of operations, including ongoing clinical research programs....more
In the context of an evolving COVID-19 response, there have between two notable regulatory developments relating to the Health Insurance Portability and Accountability Act (“HIPAA”) since the guidance issued by the Department...more
The Department of Justice (“DOJ”) Antitrust Division and the Federal Trade Commission (“FTC”) recently released a draft of their updated Vertical Merger Guidelines (the “Guidelines”), the first update since 1984. ...more
On November 15, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published its final rule outlining changes to the Medicare Physician Fee Schedule (“PFS”) for the Calendar Year (“CY”) 2020 (“Final Rule”)....more