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
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
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
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 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
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
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
The Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. This article outlines the goals of the plan, as well as challenges in healthcare that ONC hopes the...more
2/4/2020
/ 21st Century Cures Act ,
CEHRT ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Health Care Providers ,
Information Technology ,
Medical Research ,
Patient Privacy Rights ,
PHI ,
Strategic Planning ,
Technology ,
Value-Based Care
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
A recent update to the Office of Management and Budget (OMB) website suggests that the answer is “yes”—though that depends on how one defines “soon.” According to its website, OMB received the Office of the National...more
SAMHSA has released a long-awaited proposed rule that would modify the federal regulations at 42 CFR Part 2 (Part 2) governing the confidentiality of substance use disorder (SUD) patient records created by federally assisted...more
9/12/2019
/ Comment Period ,
Confidential Information ,
Consent ,
Disclosure Requirements ,
Health Care Providers ,
HIPAA Privacy Rule ,
Information Sharing ,
Medical Records ,
Opioid ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Proposed Rules ,
Public Comment ,
SAMHSA ,
Substance Abuse
The ONC recently released a proposed rule under the 21st Century Cures Act to promote interoperability of health IT and advance access, exchange or use of electronic health information. If finalized, the proposed rule would...more
3/28/2019
/ 21st Century Cures Act ,
APIs ,
Conditional Certification ,
Cost Recovery ,
Data Blocking ,
Data Privacy ,
Data Protection ,
Data-Sharing ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Information Technologies ,
License Fees ,
ONC ,
Proposed Rules
CMS issued a long-awaited proposed rule aimed at enhancing interoperability and increasing patient access to health information. If finalized, CMS’s proposed rule may require hospitals and payors to make significant...more
2/21/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Conditions of Participation (CoP) ,
Data Collection ,
Data-Sharing ,
Electronic Medical Records ,
Health Care Providers ,
Health Information Technologies ,
Hospitals ,
Medicaid ,
Medical Records ,
Medicare ,
Patient Access ,
Proposed Rules ,
Public Comment ,
Qualified Health Plans ,
Request For Information
The ONC finally released its long-awaited proposed rule to implement the “information blocking” prohibition of the 21st Century Cures Act by identifying conduct that is not information blocking. If finalized, ONC’s proposed...more
2/15/2019
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Data Privacy ,
Data Protection ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Exceptions ,
Health Care Providers ,
Health Information Technologies ,
Hospitals ,
ONC ,
Patient Privacy Rights ,
Policies and Procedures ,
Proposed Rules ,
Public Comment ,
Regulatory Agenda ,
Regulatory Requirements
In September, the Office of the National Coordinator for Health Information Technology (ONC) announced that it is scaling back requirements for third-party certification of criteria related to certified electronic health...more
On January 18, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) released its long-awaited final rule amending the confidentiality regulations at 42 CFR Part 2 (Part 2) that apply to federally...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