On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more
7/9/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Chevron v NRDC ,
Corner Post Inc v Board of Governors of the Federal Reserve System ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
4/25/2024
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Review Act ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
GAO ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
NIST ,
Nursing Homes ,
OIG ,
OIRA ,
OMB ,
Payment Systems ,
PHI ,
Policies and Procedures ,
Prescription Drugs ,
Presidential Elections ,
Proposed Guidance ,
Regulatory Agenda ,
Regulatory Standards ,
Rulemaking Process
On February 8, 2024, the Centers for Medicare and Medicaid Services (CMS) released a memorandum from the Quality, Safety & Oversight Group (QSOG) updating its 2018 guidance on texting patient information among healthcare...more
On December 13, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a wide-ranging final rule, Health Data, Technology, and...more
Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more
1/5/2024
/ AHRQ ,
Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Transparency
Key Points -
President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more
11/13/2023
/ Abbreviated New Drug Application (ANDA) ,
Artificial Intelligence ,
Critical Infrastructure Sectors ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HITECH Act ,
Joe Biden ,
Life Sciences ,
Machine Learning ,
ONC ,
Popular
On April 27, 2023, Washington Governor Jay Inslee signed the My Health My Data Act (the “Act”) into law, establishing new limits on the collection, use and sharing of “consumer health data” and creating numerous compliance...more
On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed rule, Health Data, Technology, and...more
On February 1, 2023, the Federal Trade Commission (FTC) announced that it had taken enforcement action against prescription drug discount company GoodRx, which agreed to injunctive relief and to pay a $1.5 million civil...more
Key Points -
Three of the four bipartisan leaders of the House and Senate committees with jurisdiction over data privacy have struck a deal on a comprehensive federal bill, the American Data Privacy and Protection Act,...more
The Connecticut Data Privacy Act (CTDPA), which will go into effect July 1, 2023, is now the fifth and latest comprehensive state consumer privacy law, giving companies doing business in the state less than two years to...more
With the recent signing of the Utah Consumer Privacy Act (UCPA) by Gov. Spencer J. Cox on March 24, 2022, Utah has become the fourth state to enact a comprehensive law addressing consumer data privacy, joining California,...more
To account for legal developments since our last FAQ concerning employer COVID-19 vaccination policies, we provide updated answers to questions and address additional questions about discrimination, wage and hour, collective...more
8/9/2021
/ Americans with Disabilities Act (ADA) ,
Civil Rights Act ,
Coronavirus/COVID-19 ,
Employee Incentive Plans ,
Employer Liability Issues ,
Employment Policies ,
Equal Employment Opportunity Commission (EEOC) ,
GINA ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
NLRB ,
Pregnancy Discrimination Act (PDA) ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Reasonable Accommodation ,
Title VII ,
Vaccinations ,
Workplace Safety
Key Points:
- Vaccinations for COVID-19 are picking up steam around the country as supply increases and eligibility expands.
- Now is the time for employers to think through issues raised by employee vaccination...more
4/6/2021
/ Americans with Disabilities Act (ADA) ,
Centers for Disease Control and Prevention (CDC) ,
Civil Rights Act ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Employer Liability Issues ,
Employer Mandates ,
Equal Employment Opportunity Commission (EEOC) ,
Fair Labor Standards Act (FLSA) ,
Food and Drug Administration (FDA) ,
GINA ,
Infectious Diseases ,
NLRA ,
Title VII ,
Vaccinations ,
Wage and Hour ,
Workplace Safety
On March 9, 2021, the U.S. Department of Health and Human Services Office for Civil Rights announced that the public comment period for the HIPAA proposed privacy rule would be extended until May 6, 2021. The rulemaking was...more
On January 21, 2020, the far-reaching HIPAA Privacy Proposed Rule, initially released on December 10, 2020, was published in the Federal Register. Despite speculation that the publication timeline would be altered when the...more
3/3/2021
/ Business Associates ,
Covered Entities ,
Cybersecurity ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Proposed Rules
Today, the far-reaching HIPAA Privacy Proposed Rule, initially released on December 10, 2020, was posted for public inspection on the Federal Register website. The rule is scheduled to be published in the Federal Register on...more
- On May 1, 2020, the ONC Interoperability, Information Blocking, and Health IT Certification Program Final Rule and the CMS Interoperability and Patient Access Final Rule were published in the Federal Register, marking the...more
5/4/2020
/ Blocking Statutes ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Coronavirus/COVID-19 ,
Data Blocking ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Final Rules ,
Health Care Providers ,
Health Information Technologies ,
Information Technology ,
OIG ,
ONC
As COVID-19 continues to spread, health care providers, health plans and employers are facing difficult privacy questions as they attempt to balance privacy concerns against the need to protect patients, employees and...more
3/27/2020
/ Coronavirus/COVID-19 ,
Data Privacy ,
Employee Privacy Rights ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
Patient Privacy Rights ,
PHI ,
Privacy Laws ,
Privacy Policy ,
Public Health
- The California Attorney General Office (AGO) issued revised proposed regulations (Version 2) regarding the California Consumer Privacy Act on February 7, 2020. The AGO will collect comments on the revised regulations until...more
2/21/2020
/ California Consumer Privacy Act (CCPA) ,
Comment Period ,
Consumer Privacy Rights ,
Data Collection ,
Data Privacy ,
Data Protection ,
Data Security ,
Notice Requirements ,
Opt-Outs ,
Personally Identifiable Information ,
Privacy Policy ,
Proposed Regulation ,
Public Comment ,
Right to Delete ,
Right To Know ,
State Attorneys General
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
1/8/2020
/ Acquisitions ,
Artificial Intelligence ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
CFIUS ,
Department of Health and Human Services (HHS) ,
Digital Health ,
EU ,
Export Controls ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Innovation ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Mergers ,
Office of Foreign Assets Control (OFAC) ,
Patent-Eligible Subject Matter ,
Pharmaceutical Industry ,
Popular ,
Section 101 ,
USPTO
• The Draft Regulations introduced by the California Attorney General’s Office on October 10, 2019 are subject to a public comment period and public hearings that will close on December 6, 2019. Now is the time to act to try...more
10/29/2019
/ California Consumer Privacy Act (CCPA) ,
Comment Period ,
Consumer Privacy Rights ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Protection ,
Opt-Outs ,
Personal Data ,
Personally Identifiable Information ,
Privacy Laws ,
Privacy Policy ,
Proposed Regulation ,
Public Comment ,
Right to Delete ,
Right To Know ,
State Attorneys General
On May 29, 2019, Nevada’s governor approved a new privacy law, Senate Bill 220 (“SB 220”). SB 220 amends existing state law that requires operators of websites and online services (“Operators”) to post privacy notices on...more
9/12/2019
/ California Consumer Privacy Act (CCPA) ,
Consumer Privacy Rights ,
Corporate Counsel ,
Data Collection ,
Data Privacy ,
Data Protection ,
Data Rights ,
Data Security ,
Data Use Policies ,
New Legislation ,
Online Platforms ,
Operators ,
Opt-Outs ,
Permanent Injunctions ,
Personally Identifiable Information ,
Privacy Laws ,
Privacy Policy ,
Private Right of Action ,
State Data Privacy Laws ,
Statutory Penalties ,
Third-Party Service Provider ,
Websites
On September 4, 2019, the Federal Trade Commission (FTC or the “Commission”) announced a settlement with YouTube and its parent Google that resolves allegations that the companies violated the Children’s Online Privacy...more
9/10/2019
/ COPPA ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Protection ,
Data Security ,
Federal Trade Commission (FTC) ,
Google ,
Mobile Apps ,
Online Safety for Children ,
Parental Consent ,
Personally Identifiable Information ,
Privacy Policy ,
Settlement ,
Settlement Offer ,
Statutory Penalties ,
Statutory Violations ,
Website Owner Liability ,
Websites ,
YouTube
• New York recently enacted the Stop Hacks and Improve Electronic Data Security (SHIELD) Act, which expands data breach notification requirements and imposes new data security obligations on businesses that own, license or,...more
8/5/2019
/ Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Governor Cuomo ,
HIPAA Breach ,
New Legislation ,
Personally Identifiable Information ,
Popular ,
SHIELD Act ,
State Data Breach Notification Statutes