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California’s “Physicians Make Decisions Act” Regulates the Use of AI in Insurance Decisions
By Staff
In Healthcare Law
Posted April 18, 2025

California’s “Physicians Make Decisions Act” Regulates the Use of AI in Insurance Decisions

California’s “Physicians Make Decisions Act,” effective January 1, 2025, requires human oversight of the use of artificial intelligence in medical treatments and decisions.

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Artificial Intelligence Uses in The Healthcare Industry
By Staff
In Healthcare Law
Posted May 15, 2024

Artificial Intelligence Uses in The Healthcare Industry

Artificial manufacturers need to understand the FDA approval process for medical devices and drugs. Physicians need to understand AI uses and patient privacy issues.

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The Possibilities and Legal Risks of ChatGPT for Doctors and Medical Practices
By Staff
In Healthcare Law
Posted June 8, 2023

The Possibilities and Legal Risks of ChatGPT for Doctors and Medical Practices

ChatGPT will help doctors and medical practices keep better records, review medications, track diseases, and monitor patients. Healthcare providers need to understand the legal rules that govern [...]

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Compliance and Regulatory Issues for Technical Companies and Ventures
By Staff
In Healthcare Law, Telemedicine & E-Health
Posted July 8, 2021

Compliance and Regulatory Issues for Technical Companies and Ventures

Regulatory compliance and business transactional review of digital health companies and practices including telemedicine, medical software, health hardware, and the IoT.

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Compliance Concerns for Artificial Intelligence and Telemedicine
By Staff
In Healthcare Law
Posted September 15, 2020

Compliance Concerns for Artificial Intelligence and Telemedicine

Developers are working on new AI programs that enhance, support, or enable telemedicine. New uses include diagnostic tools and online tools that have legal compliance pitfalls

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Artificial Intelligence and the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
By Staff
In Healthcare Law
Posted August 15, 2020

Artificial Intelligence and the Health Insurance Portability and Accountability Act of 1996 (HIPAA)

AI in the healthcare industry almost by definition, requires constant access to patient information. Developers and covered health providers need to understand when and how HIPAA applies to their [...]

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Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Part Two
By Staff
In Healthcare Law
Posted July 15, 2020

Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Part Two

Key provisions of the FDA’s proposed regulatory framework of software that uses and adapts to artificial intelligence and machine learning

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Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)
By Staff
In Healthcare Law
Posted June 15, 2020

Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)

The FDA has a new proposal for approving AI and ML software that looks at the total product lifecycle from development to post-market uses and the adaptations the software learns

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FDA Policy on When Software that Uses Artificial Intelligence and Machine Learning qualifies as a Medical Device
By Staff
In Healthcare Law
Posted May 15, 2020

FDA Policy on When Software that Uses Artificial Intelligence and Machine Learning qualifies as a Medical Device

As more artificial intelligence products become available, the FDA is reevaluating its approval criteria. For now, De novo approval and 501(k) are being used along with premarket approval.

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Transcendence: Is AI Energy Healing Feasible in the age of Superintelligence?
0
By Michael H Cohen
In General, Healthcare Law, Musings
Posted October 22, 2016

Transcendence: Is AI Energy Healing Feasible in the age of Superintelligence?

While I can't claim Marvin Minsky as a mentor I knew personally, his work did influence me--particularly his suggestion that the us v. them version of humans and robots (or AI) in the movies is [...]

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A Benevolent Artificial Intelligence Will Usher In Utopia
0
By Michael H Cohen
In Business Law, FDA & FTC Law, Healthcare Law
Posted January 15, 2016

A Benevolent Artificial Intelligence Will Usher In Utopia

A benevolent AI (artificial intelligence) could usher in utopia... but will augmented intelligence destroy it?

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Will Artificial Intelligence Healthcare Lawyers Augment or Replace Human Attorneys
0
By Michael H Cohen
In Healthcare Law, Law Firm News
Posted October 8, 2015

Will Artificial Intelligence Healthcare Lawyers Augment or Replace Human Attorneys

Will artificial intelligence (AI) replace or augment professional human functions such as the analytical prowess and advisory skill of a talented attorney, as machine intelligence evolves, and [...]

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Superintelligence,  Artificial Intelligence, The Singularity, & Life in the Universe
0
By Michael H Cohen
In FDA & FTC Law, Musings
Posted June 8, 2015

Superintelligence, Artificial Intelligence, The Singularity, & Life in the Universe

Today a client asked me, "are you worried about the drought?" I said, "No, I'm worried about AI eating the world."

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