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 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
Federal and state agencies continue to remain active this year, particularly with regard to laws that impact healthcare technology. As part of our ongoing efforts to track health technology-related legislation and...more
3/8/2024
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Guidance Update ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Audits ,
Innovative Technology ,
Opioid ,
SAMHSA ,
Telehealth ,
Texting ,
Waivers
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
On June 27th, Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) posted its final rule (Final Rule), which amends the OIG’s civil monetary penalty (CMP) regulations to implement the...more
6/30/2023
/ 21st Century Cures Act ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Blocking Rules ,
Information Technology ,
OIG ,
Self-Disclosure Requirements ,
Software Developers
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 November 28, 2022, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Substance Abuse Mental Health Services Administration (SAMHSA) announced a Notice of Proposed Rulemaking...more
12/6/2022
/ Business Associates ,
CARES Act ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Medical Records ,
NPRM ,
OCR ,
SAMHSA ,
Substance Abuse
Key Takeaways -
..In response to the COVID-19 pandemic, the White House Office of Science & Technology Policy and the Office of the National Coordinator for Health Information Technology take a major step towards testing...more
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
To coincide with the 32nd anniversary of the Americans with Disabilities Act (ADA), the Department of Health and Human Services Office for Civil Rights (OCR) and the Department of Justice’s Civil Rights Division (CRT)...more