On September 28, 2022, the US Food and Drug Administration (FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance. The final guidance refines and...more
The Advanced Medical Technology Association (AdvaMed) announced its revised Code of Ethics on Interactions with Health Care Professionals (2022 Code) on March 18, 2022. Notable updates to the 2022 Code provide guidance on...more
In keeping with — and in response to — HHS-OIG’s November 2020 Special Fraud Alert on industry speaker programs, the Pharmaceutical Research and Manufacturers of America has updated its Code on Interactions with Health Care...more
On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more
9/28/2020
/ Comment Period ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Labeling ,
Motion for Reconsideration ,
Motion To Stay ,
Off-Label Use ,
Proposed Rules ,
Public Health Service Act ,
Repeal
Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more
7/23/2020
/ Business Opportunities ,
Collaboration ,
Coronavirus/COVID-19 ,
Data Collection ,
Data Privacy ,
Digital Data ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Medical Research ,
Medical Technology Companies ,
Pharmaceutical Industry ,
Public Health ,
Real World Evidence ,
Research and Development ,
Webinars
On March 26, 2020, the US Food and Drug Administration issued FAQs on 3D printing of medical devices, accessories, components and parts during the Coronavirus (COVID-19) pandemic. While the use of 3D printers can help address...more
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine
The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more
10/17/2019
/ 21st Century Cures Act ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Public Comment ,
Regulatory Oversight ,
Software
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more
8/28/2019
/ Algorithms ,
Artificial Intelligence ,
Comment Period ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Machine Learning ,
Manufacturers ,
Medical Devices ,
Public Comment ,
Regulatory Oversight ,
Software Developers ,
White Papers
In its first update in a decade and effective January 1, 2020, the revised Advanced Medical Technology Association (AdvaMed) Code of Ethics in Interactions with Health Care Professionals (Code) in the United States contains...more
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more
1/21/2017
/ 21st Century Cures Act ,
Ambulatory Surgery Centers ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Long Term Care Facilities ,
Manufacturers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
MedPAC ,
Mental Health ,
Mental Health Parity Rule ,
National Institute of Health (NIH) ,
Off-Campus Departments ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Research and Development ,
Small Business ,
Substance Abuse ,
Telehealth ,
Transparency