The Joint Commission and the Coalition for Health AI released non‑binding guidance outlining principles for the responsible use of AI in healthcare including governance, privacy and transparency, data security, safety event...more
11/6/2025
/ Artificial Intelligence ,
Bias ,
Data Privacy ,
Data Security ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
New Guidance ,
PHI ,
Regulatory Oversight ,
Risk Assessment ,
Risk Management ,
Transparency
The FDA has requested comments on current, practical ways to measure and manage real-world performance of artificial intelligence-enabled devices, including those that use generative AI. ...more
Life sciences companies racing to harness artificial intelligence often stumble into preventable traps that can derail innovation and create lasting legal exposure. ...more
8/14/2025
/ Artificial Intelligence ,
Biotechnology ,
Data Privacy ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management ,
Strategic Planning
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
1/15/2025
/ Artificial Intelligence ,
Comment Period ,
Compliance ,
Data Management ,
Draft Guidance ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management
An inventor develops an invention, files a patent application and assigns the application for value to the company they founded. Later, the inventor founds another company and develops an improved version of their original...more
In This Issue -
A Looming AI War: Transparency v. IP Rights -
As artificial intelligence systems become more prevalent in daily life, efforts to create a unifying set of AI principles have intensified. In the past few...more
8/21/2019
/ Artificial Intelligence ,
Attorney's Fees ,
Bayh-Dole Act ,
Copyright ,
Copyright Infringement ,
Copyright Litigation ,
Defend Trade Secrets Act (DTSA) ,
Federal Funding ,
First Amendment ,
Free Speech ,
Iancu v. Brunetti ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Inventions ,
Lanham Act ,
Litigation Fees & Costs ,
Patent Applications ,
Patent Infringement ,
Patent Reform ,
Patent-Eligible Subject Matter ,
Patents ,
Scandalous/Immoral Marks ,
Trademarks
Federal grants are an important source of funding for many businesses and research institutions. The Bayh-Dole framework provides contractors the ability to retain title to an invention developed using federal funding, but...more
8/21/2019
/ Bayh-Dole Act ,
Disclosure Requirements ,
Employee Inventors ,
Federal Contractors ,
Federal Funding ,
Federal Grants ,
Filing Deadlines ,
Inventions ,
IP License ,
Notice Requirements ,
Patent Applications ,
Patents ,
Representations and Warranties ,
Statutory Requirements
It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the...more