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 "Counsel That Cares," HIPAA and healthcare privacy attorneys Beth Pitman and Shannon Hartsfield dissect the highly publicized Dinerstein v. Google case. They address the implications and concerns of sharing...more
Providing care via electronic communication when patients and providers are in separate locations, known as telemedicine or telehealth, has been possible for decades. The exigent circumstances sparked by the COVID-19 pandemic...more
New Florida legislation, Senate Bill 768 (2023), amending the Patient Self-Referral Act of 1992 (the Act), also known as the Florida "mini-Stark law," has been signed by Gov. Ron DeSantis and is set to take effect on July 1,...more
The Federal Trade Commission (FTC) is on a roll in its efforts to signal to the digital health industry that data privacy must be a priority. The FTC announced a consent decree with BetterHelp on March 2, 2023, to settle...more
3/7/2023
/ Advertising ,
Consent Decrees ,
Consumer Privacy Rights ,
Cookies ,
Digital Health ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Marketing ,
Mental Health ,
Telehealth ,
Unfair or Deceptive Trade Practices
The COVID-19 public health emergency (PHE) is set to expire on May 11, 2023, and there seems to be a scramble to extend some of the pandemic-related flexibilities involving telehealth. On March 1, 2023, the Drug Enforcement...more
For the first time ever, the Federal Trade Commission (FTC) is seeking enforcement under the Health Breach Notification Rule. This regulation requires certain businesses not covered by the Health Insurance Portability and...more
2/3/2023
/ Breach Notification Rule ,
Consent ,
Corporate Counsel ,
Data Breach ,
Data-Sharing ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
HIPAA Breach ,
HIPAA Breach Notification Rule ,
Mobile Apps
For years, patients and healthcare companies have been wrestling with privacy issues relating to cookies, pixels and other tracking technologies. The U.S. Department of Health and Human Services' (HHS) Office of Civil Rights...more
12/5/2022
/ Data Breach ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
New Guidance ,
OCR ,
Personally Identifiable Information ,
PHI ,
Popular ,
Tracking Systems ,
Web Tracking
Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more
11/3/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Cost-Sharing ,
Fraud and Abuse ,
Generic Drugs ,
Health Care Providers ,
Medicare ,
Medicare Part D ,
OIG ,
Out-of-Pocket Expenses ,
Patient Assistance Programs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Subsidies
Telehealth has been around for decades, but restrictive reimbursement rules kept it out of widespread use for many treatment needs. Then along came the COVID-19 pandemic and everything changed rapidly. Suddenly, due to the...more
10/5/2022
/ Compliance ,
Coronavirus/COVID-19 ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
GAO ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Reports ,
Medical Reimbursement ,
OCR ,
Patient Privacy Rights ,
Telehealth ,
Telemedicine
If a Health Insurance Portability and Accountability Act (HIPAA)-covered entity experiences a data breach involving fewer than 500 individuals, the incident must be reported to the U.S. Department of Health and Human Services...more
New federal regulations have been proposed that will affect licensure of wholesale drug distributors and third-party logistics providers (3PLs). The Drug Supply Chain Security Act became law in 2013. The U.S. Food and Drug...more
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
The Federal Trade Commission (FTC) adopted a policy statement on Sept. 15, 2021, emphasizing that developers of digital health apps, connected devices and other health products have obligations under the Health Breach...more
9/27/2021
/ App Developers ,
Breach Notification Rule ,
Business Associates ,
Covered Entities ,
Federal Trade Commission (FTC) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Mobile Apps ,
Mobile Health Apps ,
Notice Requirements ,
PHI
An amendment to the Health Information Technology for Economic and Clinical Health (HITECH) Act was signed into law on Jan. 5, 2021, directing U.S. Health and Human Services (HHS) to consider "recognized security practices"...more
8/31/2021
/ Compliance ,
Covered Entities ,
Cybersecurity ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Industry Cybersecurity Practices (HICP) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Incident Response Plans ,
New Legislation ,
NIST ,
PHI
The Emergency Medical Treatment and Active Labor Act of 1986 (EMTALA) is designed to prevent patient "dumping." It applies to all individuals coming to the emergency department (ED) of a hospital that accepts Medicare...more
Companies in the healthcare space sometimes tout to prospective customers that they are "Health Insurance Portability and Accountability Act (HIPAA) compliant." A recent Federal Trade Commission (FTC) settlement suggests that...more
To date, there has been little consistency in how Health Insurance Portability and Accountability Act (HIPAA) requirements are enforced by the U.S. Department of Health and Human Services (HHS), or the amount of settlements...more
2/5/2021
/ Anti-Kickback Statute ,
Attorney-Client Privilege ,
Civil Monetary Penalty ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Dismissals ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Medicare ,
PHI ,
Physicians ,
Stark Law ,
WA Supreme Court
On Jan. 5, 2021, the President signed into law H.R. 7898, which provides even more incentive for Health Insurance Portability and Accountability Act (HIPAA)-covered entities and business associates to develop robust security...more
Privacy revisions under the Health Insurance Portability and Accountability Act (HIPAA) may be on the horizon, with some potential changes that could benefit both patients and the healthcare industry. Other changes, if...more
12/11/2020
/ Comment Period ,
Department of Health and Human Services (HHS) ,
EHR ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Records ,
NPRM ,
OCR ,
Patient Privacy Rights ,
PHI ,
Proposed Rules ,
Right of Access
On Nov. 4, 2020, the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking and proposed regulatory changes that would, effectively, cause many federal healthcare regulations to disappear...more
Several recent cases concern challenges to executive orders relating to COVID-19 limiting the ability of churches to assemble and imposing other limitations. Beginning with appellate decisions, these cases are summarized in...more
7/17/2020
/ Abortion ,
Appeals ,
Churches ,
Coronavirus/COVID-19 ,
Executive Orders ,
Fiduciary Duty ,
Free Exercise Clause ,
Governor Cooper ,
Governor Newsom ,
Governor Northam ,
Governor Pritzker ,
Governor Sisolak ,
Health Insurance ,
Injunctions ,
Operators of Essential Services ,
Public Health Emergency ,
Religious Freedom Restoration Act (RFRA) ,
Religious Institutions ,
SCOTUS ,
Shelter-In-Place ,
South Bay United Pentecostal Church v Newsom ,
Vicarious Liability
Until the COVID-19 public health emergency, the incremental emergence of telemedicine and telehealth in the modern era of healthcare delivery has been primarily fueled by efforts to lower healthcare costs, coupled with the...more
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
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