The emergence of generative machine learning models, such as ChatGPT, has led to a surge in interest in artificial intelligence (“AI”) over the past year. This increased interest extends to the health care industry, where AI...more
12/6/2023
/ Artificial Intelligence ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HITECH Act ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
New Guidance ,
OMB ,
Personally Identifiable Information ,
PHI
Recent months have seen a heightened interest in artificial intelligence (“AI”)-based technology solutions. Although AI is derived from neural networks that date back to the 1940s, new technologies such as generative AI...more
5/11/2023
/ Artificial Intelligence ,
CEHRT ,
Digital Health ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Popular ,
Proposed Rules ,
Regulatory Agenda
As we bid farewell to 2020 and look toward the uncharted territory of 2021, it is hard not to take inventory of all that has changed in such a short period. No one at the beginning of 2020 would have predicted what transpired...more
1/26/2021
/ Artificial Intelligence ,
California Consumer Privacy Act (CCPA) ,
Communications Decency Act ,
Contact Tracing ,
COPPA ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
DMCA ,
Employee Monitoring ,
FERPA ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Personal Data ,
Personally Identifiable Information ,
Ransomware ,
Van Buren v United States
Under the 21st Century Cures Act (Cures Act), the Health and Human Services (HHS) Secretary is mandated to have promulgated regulations by Dec. 13, 2017 that, among other requirements, prohibit “information blocking” as a...more
The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more
Predicting whether the activities of a mobile health application developer trigger legal obligations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) presents some new challenges – not surprising...more
Overview and General Principles -
On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...more
Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more
7/16/2014
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Insurance ,
Hospitals ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Provider Payments ,
Reporting Requirements ,
Sunshine Act