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Draft Guidance ,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
The Emergency Medical Treatment & Labor Act (EMTALA) requires a hospital with an emergency department (ED) to provide "an appropriate medical screening examination" when an individual comes to the ED and a request is made on...more
8/7/2018
/ EMTALA ,
False Claims Act (FCA) ,
Health Insurance ,
Hospitals ,
Medicaid ,
Medicare ,
Motion to Dismiss ,
Patients ,
Physicians ,
Qui Tam ,
Whistleblowers
Under HIPAA, patients have a right to information about certain disclosures, referred to as an accounting. Under the current iteration of the regulations, covered entities and business associates need not account for...more
5/15/2018
/ Accounting ,
Advanced Notice of Proposed Rulemaking (ANPRM) ,
Business Associates ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Disclosure ,
Electronic Medical Records ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
OCR ,
Patient Rights ,
Proposed Rules ,
Recordkeeping Requirements
Timely Topics -
By Shannon B. Hartsfield -
The U.S. Department of Health and Human Services (HHS) announced on Jan. 18, 2018, the creation of a new division within its Office for Civil Rights (OCR). OCR is described as...more
1/29/2018
/ Abortion ,
Affordable Care Act ,
Appeals ,
Assisted Suicide ,
BOLI ,
Breach of Contract ,
Catholic Church ,
Charter Schools ,
Church Plans ,
Churches ,
Contraceptive Coverage Mandate ,
Defamation ,
Department of Health and Human Services (HHS) ,
Employee Benefits ,
Employee Retirement Income Security Act (ERISA) ,
Establishment Clause ,
Executive Orders ,
Federal Funding ,
Federal Housing Administration (FHA) ,
Fees ,
First Amendment ,
Fourteenth Amendment ,
Freedom of Religion ,
Hospitals ,
Injunctive Relief ,
Interim Final Rules (IFR) ,
Internet ,
Medicaid ,
New Guidance ,
Nonprofits ,
OCR ,
Preliminary Injunctions ,
Priests ,
Proposed Rules ,
Public Accommodation ,
Public Health Service Act ,
Race Discrimination ,
Religious Discrimination ,
Religious Exemption ,
Religious Freedom Restoration Act (RFRA) ,
Religious Institutions ,
Religious Schools ,
Retirement Plan ,
RLUIPA ,
Same-Sex Marriage ,
Sexual Conduct ,
Sexual Orientation Discrimination ,
Summary Judgment ,
Trump v Hawaii ,
USCIS ,
Vetting
The federal Substance Abuse and Mental Health Services Administration (SAHMSA) published a Final Rule on January 3, 2018 making further changes to federal rules governing the confidentiality of substance use disorder patient...more
CMS issued a memo to state survey agency directors on December 28, 2017, to clarify CMS’s position on texting patient information. The memo, which indicates that it is effective “immediately,” states that CMS prohibits...more
The U.S. Department of Health and Human Services (HHS) has withdrawn a HIPAA rule that would have required controlling health plans (CHPs) to demonstrate compliance with certain HIPAA standards. The proposed rule, published...more
As previously reported, Florida regulators have published emergency rules requiring nursing homes and assisted living facilities (ALF) to obtain generators and fuel sufficient to keep their facilities at 80 degrees or less...more
As a result of Hurricane Irma, eight nursing home residents died after a power failure in a Hollywood, Florida nursing home. In the wake of that tragedy, on Sept. 18, 2017, Florida regulators published emergency rules...more
9/20/2017
/ Assisted Living Facilities (ALFs) ,
Disaster Preparedness ,
Elder Care ,
Emergency Generators ,
Emergency Management Plans ,
Emergency Rule ,
Healthcare Facilities ,
Hurricane Irma ,
Natural Disasters ,
New Rules ,
Nursing Homes ,
Severe Weather
The U.S. Department of Health & Human Services Office of Inspector General (OIG) has issued an “Early Alert” regarding the preliminary results of an ongoing study of potential abuse or neglect in Medicare-certified skilled...more
Medicaid -
Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law -
By Eddie Williams -
In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more
6/7/2017
/ Anti-Kickback Statute ,
Antitrust Violations ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
DSM ,
Enforcement Actions ,
Failure To Warn ,
False Claims Act (FCA) ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medicaid Act ,
Misrepresentation ,
Noerr-Pennington Doctrine ,
OCR ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmacies ,
Preemption ,
Prescription Drugs ,
Sherman Act ,
Stark Law ,
Third-Party Liability ,
Unfair or Deceptive Trade Practices ,
Warning Labels
Deadlines are looming to come into compliance with sweeping changes to the Centers for Medicare & Medicaid Services (CMS) requirements for long-term care facilities (LTC) participating in Medicare and Medicaid. The CMS final...more
10/19/2016
/ Arbitration ,
Arbitration Agreements ,
Centers for Medicare & Medicaid Services (CMS) ,
Contract Terms ,
Department of Health and Human Services (HHS) ,
Ethics ,
Federal Arbitration Act ,
Health Care Providers ,
Healthcare ,
Long Term Care Facilities ,
Long-Term Care ,
Medicaid ,
Medicare ,
Nurse Practitioners ,
OIG ,
Patients ,
Policies and Procedures ,
Privacy Concerns ,
Privacy Policy ,
Quality Assurance Programs ,
Regulatory Standards ,
Right to Privacy ,
Skilled Nursing Facility ,
Social Media ,
Social Security Act ,
Technology