As outlined in our prior client alert, the healthcare industry can breathe a temporary sigh of relief as Congress has once again acted to extend for an additional six months the Medicare telehealth flexibilities implemented...more
As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more
1/22/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Long Term Care Facilities ,
Medical Devices ,
Medicare ,
OIG ,
Patient Privacy Rights ,
Regulatory Requirements ,
Section 340B ,
Telehealth
As the summer winds down, regulatory updates related to digital health services certainly do not appear to be showing any signs of cooling off. It has been a busy summer, and below we have summarized several key updates for...more
10/2/2024
/ Algorithms ,
Anti-Discrimination Policies ,
Artificial Intelligence ,
Children's Health Insurance Program (CHIP) ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Hospitals ,
Medicaid ,
Medicare ,
PHI ,
Policies and Procedures ,
Section 1557 ,
Telehealth ,
Transparency
While most entities that are subject to the HIPAA Security Rule spend considerable time and effort ensuring that they have implemented appropriate administrate and technical safeguards to protect the health information that...more
9/6/2024
/ Cybersecurity ,
Data Security ,
Electronic Protected Health Information (ePHI) ,
Hardware ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
HIPAA Security Rule ,
Mobile Devices ,
Networks ,
OCR ,
PHI ,
Risk Mitigation
On June 24, 2024, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) issued the 21st...more
7/16/2024
/ 21st Century Cures Act ,
ACOs ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Final Rules ,
Government Investigations ,
Health Care Providers ,
Hospitals ,
Information Blocking Rules ,
Medicare Shared Savings Program ,
MIPS ,
OIG ,
ONC ,
PHI
As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and...more
1/19/2024
/ Antitrust Litigation ,
Artificial Intelligence ,
Biotechnology ,
Cannabis Products ,
Centers for Medicare & Medicaid Services (CMS) ,
Complex Corporate Transactions ,
Coronavirus/COVID-19 ,
Corporate Transparency Act ,
Electronic Protected Health Information (ePHI) ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Information Blocking Rules ,
Medical Research ,
Medicare ,
PHI ,
Private Equity ,
Recovery Audit Contractors (RACs) ,
Regulatory Oversight ,
Section 340B ,
SNF ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
On Oct. 30, President Biden signed an executive order calling for a coordinated government approach to establish new safeguards for AI safety and security in healthcare. In response to the executive order, on Dec. 14 the...more
1/2/2024
/ 21st Century Cures Act ,
Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Certification Requirements ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Executive Orders ,
Final Rules ,
Government Agencies ,
Health Care Providers ,
Information Blocking Rules ,
ONC ,
Regulatory Agencies ,
Regulatory Agenda ,
Regulatory Oversight ,
Reporting Requirements ,
Transparency
October has been a busy month for the OCR, which is tasked with enforcing the regulations issued under HIPAA. In the past week, the OCR released two new guidance documents aimed at reducing the privacy and security risks...more
11/2/2023
/ Business Associates ,
Compliance ,
Covered Entities ,
Cybersecurity ,
Data Privacy ,
Data Security ,
Employment Policies ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
New Guidance ,
OCR ,
Telehealth
On April 18, the Office of the National Coordinator for Health Information Technology (ONC) formally published its proposed rule titled Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm...more
4/20/2023
/ 21st Century Cures Act ,
Artificial Intelligence ,
Certification Requirements ,
Comment Period ,
Data-Sharing ,
Electronic Medical Records ,
Health Care Providers ,
Health Technology ,
Information Blocking Rules ,
ONC ,
Patient Privacy Rights ,
Proposed Regulation
On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the...more
8/8/2022
/ Affordable Care Act ,
Anti-Discrimination Policies ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Foreign Language ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
Medicaid ,
Medicare ,
Medicare Part B ,
National Origin ,
National Origin Discrimination ,
Notice Requirements ,
PACE ,
Proposed Rules ,
Religious Freedom Restoration Act (RFRA) ,
Section 1557 ,
Sex Discrimination ,
Title IX ,
Title VI
Given what the healthcare industry faced in 2020, the seventh edition of our Data Security Incident Response (DSIR) Report, “Disruption and Transformation,” is aptly titled. As if fighting the COVID-19 pandemic weren’t enough...more
7/1/2021
/ Coronavirus/COVID-19 ,
Cyber Attacks ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Facilities ,
Popular ,
Ransomware ,
Right of Access
Partner Vimala Devassy and Associate Kyle Gregory discuss how recent regulations issued by the U.S. Department of Health and Human Services (HHS) represent the latest effort to break down these barriers to interoperability...more
The Department of Health and Human Services’ (HHS)’ Office of the National Coordinator (ONC) published an interim final rule today delaying several key compliance deadlines in the ONC 21st Century Cures Act final rule –...more
On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) into law. While the focus of the CARES Act has been on direct financial aid to Americans, the Act also...more
With growing patient demands, advanced technology and payer restraints, healthcare providers are increasingly exploring management agreements with experienced companies to handle the daily operations of their clinical...more
The Joint Commission (TJC) and the Centers for Medicare & Medicaid Services (CMS) took a firm stance against physicians texting patient orders in a recent joint statement, clarifying that it is not acceptable for physicians...more
The HHS Office of the National Coordinator for Health Information Technology (ONC) recently published a contracting Guide to assist healthcare providers when entering into electronic health record (EHR) contracts with EHR...more