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
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 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
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
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
On Jan. 15, 2021, the Office of the National Coordinator (ONC) posted additional Frequently Asked Questions (FAQs) on information blocking. The FAQs help resolve some of the lingering questions in the industry about complying...more
On January 5, 2021, H.R. 7898 was signed into law with little fanfare, thereby amending the Health Information Technology for Economic and Clinical Health Act. As the healthcare industry continues to serve as one of the top...more
This is the second in a series of client alerts on the collaborative effort between the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS), which...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 April 9, 2020, the Office for Civil Rights (OCR) issued a Notification of Enforcement Discretion, which announced that, retroactive to March 13, OCR will not impose penalties against covered entities or business associates...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
The HHS Office for Civil Rights (OCR) issued two important bulletins this week regarding the novel coronavirus disease (COVID-19) outbreak. ...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
On June 12, 2017 the Department of Health and Human Services Office of Inspector General (OIG) released a report entitled Medicare Paid Hundreds of Millions in Electronic Health Record Incentive Payments That Did Not Comply...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