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In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials.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Draft Guidance ,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 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
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
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 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
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
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
Recently, the Centers for Medicare & Medicaid Services (“CMS”) published its annual proposed rule outlining potential changes to the Medicare Physician Fee Schedule (“PFS”) for upcoming Calendar Year (“CY”) 2020 (“Proposed...more
9/18/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Treatment ,
Health Care Providers ,
Medicare ,
Medicare Beneficiaries ,
Opioid ,
Physician Fee Schedule ,
Physicians ,
Prescribing Authority ,
SAMHSA
In this second installment of Qui Tam Quarterly, K&L Gates breaks down two policy statements by the U.S. Department of Justice ("DOJ"), providing an analysis of both (1) the 2018 "Granston Memo" and related case law; as well...more
The U.S. Department of Health and Human Services recently released a notice of enforcement discretion announcing changes in how the agency will assess civil monetary penalties for violations of the Health Insurance...more
5/9/2019
/ Civil Monetary Penalty ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Interim Final Rules (IFR) ,
Patient Privacy Rights
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