On December 13, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) issued the Health Data, Technology, and Interoperability: Certification...more
On October 30, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) released a...more
On July 3, 2023, the US Department of Health and Human Services Office of Inspector General (OIG) published its long-awaited final rule implementing the 21st Century Cures Act provisions authorizing OIG to investigate claims...more
7/10/2023
/ 21st Century Cures Act ,
Amended Rules ,
Civil Monetary Penalty ,
CMP Law ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Enforcement Actions ,
Health Care Providers ,
Health Information Technologies ,
Information Blocking Rules ,
Information Technology ,
Investigations ,
OIG ,
Proposed Rules ,
Reporting Requirements
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
On April 12, 2023, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking detailing its proposal to modify the HIPAA Privacy Rule (Proposed Rule). The...more
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) issued a Bulletin (Dec. 2022) outlining the obligations for HIPAA covered entities and businesses when deploying online tracking...more
2/10/2023
/ Continuing Legal Education ,
Cookies ,
Covered Entities ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Mobile Apps ,
OCR ,
PHI ,
Unauthorized Disclosure ,
Web Tracking ,
Webinars ,
Websites
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 June 24, 2022, the Supreme Court of the United States issued its decision in Dobbs v. Jackson Women’s Health Organization (Dobbs), overturning Roe v. Wade (Roe) and upending 50 years of precedent protecting a woman’s right...more
6/29/2022
/ Abortion ,
Continuing Legal Education ,
Dobbs v. Jackson Women’s Health Organization ,
Employee Benefits ,
Family Planning Clinics ,
Health Care Providers ,
Health Plan Sponsors ,
Pregnancy ,
Roe v Wade ,
SCOTUS ,
Webinars
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
On November 4, 2020, the US Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) published an interim final rule with comment period in the Federal Register that...more
On September 17, 2020, the Office of Management and Budget received an Interim Final Rule for review from the Office of the National Coordinator for Health IT (ONC) entitled “Information Blocking and the ONC Health IT...more
Under the Office of the National Coordinator for Health IT (ONC) 21st Century Cures Act final rule, effective July 1, 2020, health care providers, in their capacities as such, are not subject to civil monetary penalties....more
On April 21, 2020, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS) announced that they will...more
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
The Office of the National Coordinator for Health Information Technology recently released a final rule under the 21st Century Cures Act to promote interoperability of health IT and advance access, exchange or use of...more
The Centers for Medicare & Medicaid Services (CMS) published its highly anticipated final rule aimed at enhancing interoperability and increasing patient access to health information. CMS’s final rule will require hospitals...more
3/18/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Department of Health and Human Services (HHS) ,
Electronic Health Record Incentives ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Information Technology ,
Medicaid ,
Medicare ,
Qualified Health Plans
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
ONC finalized changes to the certification criteria for application programming interfaces (APIs) that have the potential to improve the ability of patients to access electronic health information through a third party...more
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
CMS's final rule requires that CMS-regulated payors implement APIs that allow patient information to be shared more readily among patients, health care providers and payors. It also imposes a new Medicare condition of...more