FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated products engage with AI. In response to the...more
9/6/2023
/ Artificial Intelligence ,
Continuing Legal Education ,
Draft Guidance ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Webinars
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
8/18/2023
/ Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
NAD ,
OPDP ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Labels ,
Warning Letters
FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more
Introduction - Enterprises are increasingly reliant on complex and interconnected ecosystems of technology solutions. Companies are reducing their dependence on the legacy monolithic highly customized solutions, instead...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Over the past decade, M&A activity has been steadily trending upward, paused only momentarily in 2020 by global pandemic concerns. Although activity is heavy across many sectors, there is particular interest and investment in...more
With the many recent, high-profile ransomware attacks, many companies are likely assessing their own cybersecurity and risks. Seeing the crippling effect a cyberattack can have on, for example, the nation’s largest...more
Our podcast series features AGG attorneys and guests discussing challenges they’ve encountered when assisting clients on business and legal issues related to the Technology industry. While all topics will have a legal...more
8/26/2021
/ Best Practices ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Information Technologies ,
Health Technology ,
Hospitals ,
Information Blocking Rules ,
Information Technology ,
ONC ,
PHI ,
Popular ,
Ransomware
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
7/26/2021
/ Cybersecurity ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Home Health Care ,
Life Sciences ,
Medical Devices ,
Medicare ,
OPDP ,
Pharmaceutical Industry ,
Pharmacies ,
Popular ,
Prescription Drugs ,
State Privacy Laws
On May 12, President Biden signed an executive order on improving the nation’s cybersecurity (the “Executive Order”). The Executive Order identified six broad initiatives for the improvement of security within federal...more
When implementing breach response policies and enterprise-level security measures, companies always consider guidance. Historically, when responding to security breaches and engaging in advance breach remediation handling,...more
In recent months, the word “ransomware” has moved from a topic discussed only among cybersecurity professionals to a term used at dinner tables and water coolers across the country. Simultaneously, in the healthcare space,...more