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
In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more
10/15/2019
/ Administrative Procedure Act ,
Affordable Care Act ,
Anti-Kickback Statute ,
Article III ,
Attorney-Client Privilege ,
Centers for Medicare & Medicaid Services (CMS) ,
Criminal Convictions ,
Dismissals ,
Disproportionate Share Adjustments ,
Draft Guidance ,
Enforcement Actions ,
European Medicines Agency (EMA) ,
False Advertising ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Lanham Act ,
Medical Devices ,
Medicare ,
Patient Engagement Advisory Committee (PEAC) ,
Patient Referrals ,
Physicians ,
Prescription Drugs ,
Standing ,
Stark Law
Healthcare providers face a dilemma when patients post complaints or make other statements on social media. Just because a patient has made certain information public does not mean that the provider can also post protected...more
10/9/2019
/ Corporate Fines ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Online Reviews ,
PHI ,
Social Networks ,
Yelp
Florida Governor Ron DeSantis recently signed House Bill 369, Chapter No. 2019-159, Laws of Florida, which became effective on July 1, 2019. The primary focus of the bill relates to substance abuse services. For example, the...more
7/3/2019
/ Anti-Kickback Statute ,
Certification Requirements ,
Exceptions ,
Governor DeSantis ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
New Legislation ,
Patients ,
Substance Abuse ,
Supervisors
As new healthcare delivery models evolve, we may see an increase in hospitals that share space with other hospitals or healthcare entities. On May 3, 2019, Centers for Medicare and Medicaid Services (CMS) issued draft...more
The federal Department of Health and Human Services' Office for Civil Rights, which enforces HIPAA, maintains a website with very helpful "frequently asked questions" (FAQs) regarding the HIPAA Privacy Rule and Security Rule....more
4/23/2019
/ App Developers ,
Covered Entities ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
EHR ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Mobile Apps ,
New Guidance ,
OCR
When a surveyor cites "immediate jeopardy" at a provider, supplier or laboratory’s location it can lead to serious consequences, including potential fines and termination from federal healthcare programs. On March 5, 2019,...more
• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more
1/14/2019
/ Best Practices ,
Cyber Attacks ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Data Loss Prevention ,
Data Privacy ,
Data Protection ,
Data Security ,
Data Theft ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
Food and Drug Administration (FDA) ,
Hackers ,
Health Care Providers ,
Health Clinics ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Hospitals ,
Information Technology ,
Medical Devices ,
NIST ,
Patient Safety ,
Personally Identifiable Information ,
PHI ,
Phishing Scams ,
Popular ,
Ransomware ,
Risk Mitigation ,
Standard of Care
On Dec. 28, 2018, the U.S. Department of Health and Human Services (HHS) announced the release of voluntary cybersecurity practices and tools for the healthcare industry. The documents were the result of Section 405(d) of the...more
1/4/2019
/ Best Practices ,
Cyber Threats ,
Cybersecurity ,
Cybersecurity Act of 2015 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Clinics ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
HITECH Act ,
NIST ,
Popular ,
Risk Mitigation
The Department of Health and Human Services' Office for Civil Rights (OCR) has issued a Request for Information, which is scheduled for publication in the Federal Register on Dec. 14, 2018. OCR is asking the public to provide...more
12/12/2018
/ Comment Period ,
Data Privacy ,
Data Security ,
Federal Register ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Sharing ,
OCR ,
PHI ,
Privacy Policy ,
Public Comment ,
Regulatory Agenda ,
Regulatory Burden ,
Request For Information ,
Value-Based Care
Another government settlement demonstrates that not having a HIPAA compliance program can be costly. U.S. Department of Health and Human Services (HHS)'s Office for Civil Rights (OCR) announced, on Dec. 4, 2018, that Advanced...more
12/6/2018
/ Corrective Actions ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Fines ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
OCR ,
Policies and Procedures ,
Regulatory Oversight ,
Risk Management ,
Settlement Agreements
HIPAA and several other privacy laws do not include a private right of action. This is cold comfort for healthcare providers, health plans and other members of the healthcare industry if a patient is able to demonstrate that...more
11/16/2018
/ Appeals ,
Breach of Duty ,
Common Law Torts ,
Data Privacy ,
Department of Corrections ,
Duty of Confidentiality ,
Fiduciary Duty ,
Former Employee ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hiring & Firing ,
Medical Records ,
Negligence ,
Patient Privacy Rights ,
Physicians ,
Privacy Laws ,
Private Right of Action
The Department of Health and Human Services' Office of the Inspector General (HHS OIG) announced a new cybersecurity website on Oct. 9, 2018.
The OIG stated that it has formed a Cybersecurity Team made up of "auditors,...more
Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more
10/2/2018
/ Comment Period ,
Deadlines ,
Draft Guidance ,
Drug Compounding ,
Drug Distribution ,
DSCSA ,
Food and Drug Administration (FDA) ,
Grandfathering Rules ,
Manufacturers ,
New Guidance ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Product Identifiers ,
Product Packaging ,
Public Comment ,
Regulatory Requirements ,
Suppliers ,
Supply Chain ,
Wholesale
Regulation -
CMS Contemplating Telemedicine Changes -
The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more
9/7/2018
/ Advisory Opinions ,
Anti-Competitive ,
Anti-Kickback Statute ,
Antitrust Litigation ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Common Ownership ,
Creditors ,
Debt Collection ,
Debtors ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Exempt-Employees ,
Failed Legislation ,
Failure To State A Claim ,
False Claims Act (FCA) ,
FDCPA ,
Former Employee ,
GPOs ,
Health Care Providers ,
Hospitals ,
Medicaid ,
Medical Reimbursement ,
Medicare ,
Medicare Shared Savings Program ,
OIG ,
Patients ,
Physician Fee Schedule ,
Physician Medicare Reimbursements ,
Physicians ,
Popular ,
Proposed Rules ,
Public Comment ,
Putative Class Actions ,
Quality Payment Program (QPP) ,
Qui Tam ,
Safe Harbors ,
Self-Referral ,
Standing ,
Stark Law ,
Summary Judgment ,
Technology Sector ,
Telehealth ,
Telemedicine ,
Whistleblowers