On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
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(FDA) issued its final Clinical Decision Support Software Guidance three years after the issuance of its 2019 revised draft guidance.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
One of the few constants in the evolving government enforcement landscape is a focus on life sciences companies and their interactions and financial relationships with providers. In this final installment of our three-part...more
6/3/2021
/ Artificial Intelligence ,
Compliance ,
Coronavirus/COVID-19 ,
Digital Health ,
Enforcement ,
Health Care Providers ,
Influencers ,
Life Sciences ,
Patients ,
Product Placement ,
Social Media ,
Webinars
Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic.
The transactional and regulatory issues as...more
In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/15/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/15/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/14/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/13/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
The Food and Drug Administration issued an enforcement policy on the use of digital health devices that are considered therapeutic for psychiatric disorders during the Coronavirus (COVID-19) public health emergency. The...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 US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more
1/14/2020
/ 21st Century Cures Act ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Drug Pricing ,
FDA Commissioner ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Oversight
Digital health and other life sciences/tech developers, particularly those producing innovative new solutions, offer dynamic opportunities for investors, in part due to the continued evolution of the US Food and Drug...more
12/2/2019
/ Biologics ,
Collaboration ,
Digital Health ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Hospitals ,
Innovation ,
Investment Management ,
Investors ,
Life Sciences ,
Medical Devices ,
Risk Management ,
Startups
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 response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more
9/18/2019
/ Cybersecurity ,
Digital Health ,
Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
PreCert Pilot Program ,
Precertification ,
Regulatory Oversight ,
Regulatory Requirements ,
Software ,
Software Developers ,
Voluntary Participation
INTRODUCTION -
The US Food and Drug Administration’s (FDA’s) 2018 regulatory agenda spurred significant activity throughout the year, including implementation of several initiatives and mandates required by the 21st...more
The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more
1/12/2018
/ 21st Century Cures Act ,
Advertising ,
Digital Health ,
Executive Orders ,
FDARA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Tobacco
Introduction -
Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
1/10/2018
/ 21st Century Cures Act ,
Artificial Intelligence ,
Biometric Information ,
Consumer Protection Act ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Health Insurance ,
Life Sciences ,
OIG ,
Privacy Policy ,
Research and Development ,
TCPA ,
Telehealth
The FDA recently released “Software as a Medical Device (SAMD): Clinical Evaluation,” a final guidance document that aims to establish a common understanding of clinical evaluation and principles for demonstrating the safety,...more
On December 7, 2017, the US Food and Drug Administration (FDA) published a highly anticipated draft guidance document that describes how the agency intends to exercise oversight over clinical decision support (CDS) software....more
August 1, 2017, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory...more
In recognition that the traditional regulatory approach toward moderate to high risk medical devices is not well-suited for current digital health software products, the US Food and Drug Administration published a Digital...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