During this session, panelists discussed the unique opportunities and challenges of digital-health wellness programs that partner with employers and health plans in considering, adopting and operationalizing wellness programs...more
In a Notice of Proposed Rulemaking published December 2, 2022 (the Proposed Rule), the United States Department of Health and Human Services (HHS) proposed long-awaited changes to the regulations protecting the...more
On December 1, 2022, the Office for Civil Rights (OCR) at the US Department of Health and Human Services (HHS) issued a Bulletin on the obligations of covered entities and business associates (regulated entities) under the...more
12/6/2022
/ Data Privacy ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Mobile Apps ,
New Guidance ,
OCR ,
Personally Identifiable Information ,
PHI ,
Tracking Systems ,
Web Tracking
Many pharmaceutical manufacturers currently require 340B covered entities to provide de-identified pharmacy claims data for dispensed 340B drugs to a third party, 340B ESP, as a condition of receiving discounts under the 340B...more
12/2/2022
/ Data Management ,
Discount Pricing ,
Drug Pricing ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Section 340B ,
Webinars
The US Supreme Court’s recent decision to overturn Roe v. Wade in Dobbs v. Jackson Women’s Health Organization has raised many questions about potential efforts by law enforcement agencies to obtain data from healthcare and...more
7/11/2022
/ Abortion ,
Biden Administration ,
Data Collection ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Electronic Protected Health Information (ePHI) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Pregnancy ,
Privacy Concerns ,
Roe v Wade ,
SCOTUS
On December 10, 2020, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Notice of Proposed Rulemaking (NPRM) with proposed modifications to the Standards for the Privacy of...more
12/18/2020
/ Department of Health and Human Services (HHS) ,
Disclosure ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Access Request ,
HIPAA Privacy Rule ,
Information Requests ,
Medicare ,
NPRM ,
OCR ,
Third-Party
As part of the CARES Act signed into law on March 27, 2020, Congress included a provision directing the secretary of Health and Human Services (HHS) to modify long-standing regulatory restrictions under the federal substance...more
On April 2, 2020, the US Department of Health and Human Services, Office for Civil Rights announced that it will not impose civil money penalties against covered entity health care providers or their business associates for a...more
On March 9, 2020, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released its long-awaited final rule identifying conduct that does not...more
As the globe grapples with increasing challenges to sustaining “business as usual” in their enterprises, our team of Employment, Employee Benefits, Health and Privacy & Cybersecurity lawyers invite you to join us for...more
3/17/2020
/ Anti-Discrimination Policies ,
Anti-Harassment Policies ,
Anti-Retaliation Provisions ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Privacy ,
Data Security ,
Data-Sharing ,
Employee Benefits ,
Employment Policies ,
Health and Safety ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Savings Accounts ,
Infectious Diseases ,
Paid Time Off (PTO) ,
Personal Data ,
Public Health ,
Quarantine ,
Remote Working ,
Risk Mitigation ,
Sick Leave ,
Webinars ,
Workplace Safety
PRIVACY, HIPAA, SECURITY AND GDPR -
The introduction and spread of COVID-19 to communities across the globe has created numerous privacy and security compliance questions and challenges. Below, we address several frequently...more
3/13/2020
/ Benefit Plan Sponsors ,
Business Associates ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Covered Entities ,
Emergency Management Plans ,
Employer Group Health Plans ,
EU ,
European Economic Area (EEA) ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
Internal Communications ,
PHI ,
Privacy Laws ,
Required Communications
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine
The US Department of Health and Human Services, Office for Civil Rights (OCR) published a long-awaited Request for Information seeking feedback on whether and how the HIPAA Rules should be revised to better promote...more
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more
1/21/2017
/ 21st Century Cures Act ,
Ambulatory Surgery Centers ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Long Term Care Facilities ,
Manufacturers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
MedPAC ,
Mental Health ,
Mental Health Parity Rule ,
National Institute of Health (NIH) ,
Off-Campus Departments ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Research and Development ,
Small Business ,
Substance Abuse ,
Telehealth ,
Transparency
On February 5, 2015, the Substance Abuse and Mental Health Administration (SAMHSA) released a long-awaited proposed rule to modify the confidentiality rules that apply to patient identifying information generated by federally...more
As we reported in May 2014, the Federal Trade Commission (FTC) convened stakeholders to explore whether health-related information collected from and about consumers — known as consumer-generated health information (CHI) —...more