In a recent settlement, the Texas attorney general resolved allegations that Pieces Technologies, Inc. (Pieces), a healthcare generative AI company, misrepresented the hallucination rate of its generative AI product to...more
12/4/2024
/ Artificial Intelligence ,
Compliance ,
Enforcement Actions ,
Health Care Providers ,
Healthcare Facilities ,
Misrepresentation ,
Risk Assessment ,
Risk Management ,
Settlement ,
Software ,
State Attorneys General
Earlier this year, Indiana joined a growing number of states by enacting a new notification requirement for certain healthcare transactions. Indiana Senate Bill Number 9 (SB 9), effective July 1, 2024, is likely to require...more
5/21/2024
/ Acquisitions ,
Corporate Practice of Medicine ,
Covered Entities ,
Health Care Providers ,
Hospitals ,
Investors ,
Mergers ,
New Legislation ,
Notice Requirements ,
Physicians ,
Popular ,
Private Equity ,
State Attorneys General ,
Threshold Requirements
On March 8, 2023, US Sens. Cory Booker (D-NJ) and Rand Paul (R-KY) introduced an updated version of the Breakthrough Therapies Act, and US Reps. Nancy Mace (R-SC) and Madeleine Dean (D-PA) introduced companion legislation in...more
Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person...more
5/19/2023
/ Comment Period ,
Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
NPRM ,
Pharmacies ,
Prescription Drugs ,
Public Health Emergency ,
SAMHSA ,
Telehealth ,
Telemedicine
The Controlled Substances Act, as amended by the Ryan Haight Act, generally prohibits prescribing controlled substances via telehealth without a prior in-person examination, subject to certain very limited exceptions. Those...more
During the COVID-19 pandemic, telehealth utilization exploded. Globally, the telehealth market is valued at $83.5 billion and is expected to grow by 24% between 2023 and 2030. As services delivered via telehealth became more...more
2/7/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Health Care Providers ,
Prescription Drugs ,
Public Health Emergency ,
Relief Measures ,
State and Local Government ,
Telehealth ,
Telemedicine ,
Waivers
Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations.
The metaverse uses technologies such as...more
1/27/2023
/ Artificial Intelligence ,
Blockchain ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Corporate Practice of Medicine ,
Digital Health ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Licensing Rules ,
Life Sciences ,
Metaverse ,
Popular ,
Regulatory Requirements ,
Regulatory Standards ,
Telehealth ,
Telemedicine ,
Virtual Reality
Millions of women use reproductive health applications (or “apps”) to track menstrual cycles, ovulation, and pregnancy. These apps provide women that use the rhythm method for birth control and women seeking to become...more
7/19/2022
/ Abortion ,
Business Associates ,
Covered Entities ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Mobile Apps ,
OCR ,
PHI ,
Reproductive Healthcare Issues ,
Sensitive Personal Information ,
State Privacy Laws ,
Technology Sector
Can human reproductive tissue (“HRT”) held by a fertility clinic serve as collateral for a loan to (or investment in) the fertility clinic? In short, the scope and extent of governmental regulation addressing the sale of or...more
7/15/2022
/ Article 9 ,
Collateral ,
Consideration ,
Healthcare Facilities ,
Organ Donation ,
Organ Transplant Centers ,
Perfected Security Interest ,
Reproductive Healthcare Issues ,
Secured Debt ,
State and Local Government ,
Uniform Commercial Code (UCC)
As of April 5, 2021, health information technology companies and developers are required to comply with the information blocking provisions of the Centers for Medicare and Medicaid Services’ (CMS) and the Office of the...more
10/8/2021
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Final Rules ,
Health Care Providers ,
Health Information Technologies ,
Information Blocking Rules ,
Information Sharing ,
OIG ,
ONC