After months of uncertainty and multiple letters from industry associations advocating on behalf of the healthcare industry with the U.S. Department of Health and Human Service (HHS) Office for Civil Rights (OCR), covered...more
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has, as part of its mandate, the responsibility to enforce the Health Insurance Portability and Accountability Act (HIPAA) Security Rule....more
5/14/2024
/ Audits ,
Business Associates ,
Compliance ,
Covered Entities ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
HITECH Act ,
OCR ,
PHI ,
Popular ,
Ransomware ,
Risk Assessment ,
Web Tracking
In the midst of an industry reeling from the Change Healthcare cybersecurity incident, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has issued a series of final rules requiring...more
House Bill 975, if signed by Gov. Ron DeSantis, will have a significant impact on the Florida criminal background screening requirements for healthcare professionals and facilities. Currently, only certain healthcare...more
3/26/2024
/ Background Checks ,
Criminal Background Checks ,
Governor DeSantis ,
Health Care Providers ,
Healthcare Facilities ,
Hiring & Firing ,
Licensing Rules ,
New Legislation ,
Nurses ,
Physicians ,
Professional License
After more than a year since the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued the proposed changes to the...more
2/26/2024
/ CARES Act ,
Civil Liability ,
Compliance ,
Confidential Information ,
Consent ,
Criminal Liability ,
Effective Date ,
Electronic Protected Health Information (ePHI) ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach Notification Rule ,
HITECH Act ,
Mental Health ,
Notice Requirements ,
OCR ,
ONC ,
Patient Privacy Rights ,
PHI ,
Public Health Emergency ,
Safe Harbors ,
SAMHSA ,
Substance Abuse
Two divisions of the U.S. Department of Health and Human Services (HHS) – the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator (ONC) – released the "21st Century Cures Act:...more
11/1/2023
/ 21st Century Cures Act ,
ACOs ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Electronic Health Record Incentives ,
Health Care Providers ,
Hospitals ,
Information Blocking Rules ,
Medicare ,
ONC ,
Proposed Rules
In this episode of our “Florida Capital Conversations” podcast series, healthcare attorneys Mia McKown, Eddie Williams and Shannon Hartsfield discuss how privacy violations can put a healthcare practitioner's license at risk....more
In this episode of our “Florida Capital Conversations” podcast series, healthcare attorney Eddie Williams joins to discuss the dissemination of electronic health information and provisions regarding information blocking. He...more
In this episode of our “Florida Capital Conversations” podcast series, healthcare attorney Shannon Hartsfield joins to discuss recent enforcement trends with regard to protected health information and the Health Insurance...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently posted the final rule establishing civil monetary penalties (CMPs) for information blocking (IB Enforcement Rule). The Rule...more
7/18/2023
/ 21st Century Cures Act ,
Bipartisan Budget Act ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Enforcement Priorities ,
Fraud Abuse and Waste ,
Fraud and Abuse ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Information Blocking Rules ,
Information Technology ,
OIG ,
ONC
The 2023 Florida legislative session came to a close on May 5, 2023. The Legislature was very active and passed approximately 200 bills, including several that will impact the healthcare regulatory landscape. Once approved by...more
5/12/2023
/ Anti-Discrimination Policies ,
Covered Entities ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Foreign Entities ,
Governor DeSantis ,
Health Care Providers ,
Medical Records ,
Patient Privacy Rights ,
Patients ,
Pending Legislation ,
State Health Departments
The U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) on April 11, 2023, released a Notice of Proposed Rule Making called the Health Data,...more
4/28/2023
/ Artificial Intelligence ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Technology ,
Information Blocking Rules ,
Machine Learning ,
NPRM ,
ONC ,
PHI ,
Proposed Amendments ,
Proposed Rules
The full scope of electronic health information (EHI), as defined under the information blocking regulation (Regulation), is now subject to the prohibition against information blocking. Under the Regulation, information...more
The 21st Century Cures Act Information Blocking Rule, codified at 45 CFR Part 171, is intended to enhance access to, exchange or use of electronic health information (EHI), and generally prohibits "actors" from knowingly...more
Patients may think they own their medical records. While patients certainly have the right to access and, in many cases, control how their health information is used and disclosed, medical records ownership can be murky....more
2/9/2022
/ 21st Century Cures Act ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Blocking Rules ,
Medical Records ,
ONC ,
Patient Access ,
Physicians
Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more
10/18/2021
/ Abuse of Discretion ,
Anti-Kickback Statute ,
Appeals ,
Attorney-Client Privilege ,
Comment Period ,
Criminal Investigations ,
Discovery ,
Draft Guidance ,
Evidence ,
Failure To State A Claim ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Kickbacks ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Patient Referrals ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Scienter
Florida House Bill 241, which has been presented to Gov. Ron DeSantis, creates the Parents' Bill of Rights in Chapter 1014, Florida Statutes, under the Florida K-20 Education Code. The bill prohibits the state, its political...more
In summer 2020, the Office of the National Coordinator for Health Information Technology (ONC) published a final rule on interoperability, information blocking and patient access to data. The rule implements certain...more
Earlier this year, the Office of the National Coordinator for Health Information Technology (ONC) published a final rule (ONC Rule) addressing interoperability, information blocking and patient access to data. The ONC Rule...more
10/20/2020
/ 21st Century Cures Act ,
Coronavirus/COVID-19 ,
Criminal Convictions ,
Damages ,
Department of Health and Human Services (HHS) ,
Double Damages ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Information Blocking Rules ,
Kickbacks ,
Medical Devices ,
Medical Records ,
Medicare ,
ONC ,
PACT Act ,
Self-Referral ,
Willful Violations
This Holland & Knight alert aggregates Florida developments and will be updated on a regular basis. Please note that the situation surrounding COVID-19 is evolving and that the subject matter discussed in these publications...more
In response to the threat of the spread of the coronavirus (COVID-19), the Centers for Medicare and Medicaid Services (CMS) has issued a memorandum to State Survey Agencies and Accrediting Organizations, suspending all...more
Neurosurgeons' Compensation in Top 10 Percent Nationwide Gives Rise to Stark Act and FCA Claims -
In United States ex re. Bookwalter v. UPMC, 946 F. 3d 162 (3d Cir. 2019), the court ruled that the relators stated a Stark...more
2/25/2020
/ Americans with Disabilities Act (ADA) ,
Anti-Kickback Statute ,
Assisted Living Facilities (ALFs) ,
Centers for Medicare & Medicaid Services (CMS) ,
Diagnostic Tests ,
DMEPOS ,
Durable Medical Equipment ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Grants ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Objective Falsity ,
Ownership Interest ,
Physicians ,
Protected Activity ,
Stark Law
With the start of the 2019 Florida Legislative Session, several proposed bills could have significant impact on the healthcare landscape in the state. The following are brief highlights of some of the bills that have been...more
Allergy Associates of Hartford, P.C., entered into a Resolution Agreement and agreed to pay $125,000 to the U.S. Department of Health and Human Services, Office for Civil Rights (HHS) in order to settle certain Health...more
On Nov. 16, 2018, the Florida Department of Revenue renewed Emergency Rule 12AER18-02, which implemented Section 56, Chapter 2018-118, Laws of Florida, providing for a sales tax exemption for equipment purchased to generate...more
11/21/2018
/ Assisted Living Facilities (ALFs) ,
Department of Revenue ,
Elder Care ,
Electricity ,
Emergency Generators ,
Emergency Rule ,
Health Care Providers ,
Nursing Homes ,
Sales Tax ,
Tax Exemptions ,
Tax Refunds