Federal agencies that use artificial intelligence to approve drugs and medical devices or decide who gets access to health care in government programs would have to follow new protocols under a draft White House directive released yesterday.

How so? The memo from the Office of Management and Budget defines decisions it views as either “rights-impacting” or “safety-impacting” and spells out what agencies must do when they use AI to make such choices.

Rights-impacting decisions include those on approvals of medical devices or drugs, drug-addiction risk assessments, mental-health status to flag patients for interventions and the allocation of public insurance .

Safety-impacting decisions include those involving human life, serious injury, bodily harm, biological or chemical harm, occupational hazards, harassment or abuse or mental health, including both individual and community aspects of the harms.

Agencies using AI to make either type of decision would assign a new chief AI officer to:

— Complete an AI impact assessment detailing the AI’s purpose and its expected benefit, the potential risks and the quality of the data undergirding the decision-making.

— Test the AI for performance in a real-world context and independently evaluate the AI.

— Conduct ongoing monitoring and establish thresholds for periodic human review.

Additional protocols would be established for AI-driven decisions affecting rights, including:

— An evaluation of whether the AI will advance equity, dignity and fairness

— Consultations with affected groups

— Ongoing monitoring for discrimination

— Notification of negative impacts

What’s next? To implement the guidance, agencies will need unspecified additional funding, which the White House said it would include in its fiscal 2025 budget request to Congress early next year, POLITICO’s Mohar Chatterjee reported.

The OMB will take comments on the draft guidance through Dec. 5 and finalize the memo in early 2024.

This is where we explore the ideas and innovators shaping health care.

China and the United States are inching towards cooperation on artificial intelligence, with both among the 27 countries to sign a pledge in the U.K. yesterday to establish a network to research the risks of the new technology. Commerce Secretary Gina Raimondo also took the stage during the summit at Bletchley Park with Wu Zhaohui, China’s vice minister of science.

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Next week, Future Pulse will cover the Milken Institute’s Future of Health Summit, one of the most important global health events of the year. We’ll report on the policy, politics and trends impacting the future of health care at Milken from Nov. 6-8.

Today on our Pulse Check podcast, your host Evan talks with POLITICO health care reporter Kelly Hooper, who explains the Affordable Care Act open enrollment process and changes for 2024, such as higher premiums and different plan choices, and how federal, and in some cases state, subsidies are expected to shield most enrollees from cost hikes.

Harvard University is launching a program to study psychedelics in society and culture with a $16 million gift from the Gracias Family Foundation.

The interdisciplinary program spans the law, arts and science and divinity schools. Instead of approaching the psychedelics from a strictly health and medicine perspective, it will include wide-ranging study through law, policy, ethics, religion, art and literature lenses.

What’s new? Michael Pollan, Harvard professor and author of the book “How to Change Your Mind,” about his experience experimenting with psychedelic drugs, told the Harvard Crimson that focusing on the humanities instead of scientific research sets the gift apart from existing funding.

“Psychedelics are a cultural phenomenon as well as a medical phenomenon. They have huge implications for law and policy as we kind of stumbled toward approval and legalization,” Pollan said.” So I think it’s wonderful that these other dimensions of psychedelics are going to get studied.”

Dig deeper: The Gracias Family Foundation’s president is Antonio Gracias, a private equity investor and a former director of Tesla.

Other big names who’ve donated significant money to various organizations for psychedelic study include Blake Mycoskie, founder of Toms Shoes, who pledged $100 million toward psychedelic research earlier this year. He’s given away $11 million of that so far, he recently told Bloomberg.

On the Hill: The Food and Drug Administration, as well as members of Congress — including Reps. Alexandria Ocasio-Cortez (D-N.Y.), Lou Correa (D-Calif.), Dan Crenshaw (R-Texas) and Jack Bergman (R-Mich.) — have pushed for more study of psychedelics as a potential treatment for mental illness.

The maker of ChatGPT, the bot that can pass medical exams, is looking for help in Washington just as President Joe Biden is proposing new AI regulations.

OpenAI has no registered lobbyists but seeks a “US Congressional Lead” to join its global affairs team.

What the successful candidate will bring:

— An established Capitol Hill network and credibility with colleagues on both sides of the aisle in the House and Senate

— Demonstrated knowledge and understanding of the U.S. political system, institutions and processes and the key policy issues and debates related to AI

— Experience managing relationships with civil society, researchers and other stakeholders, including underrepresented groups

What the lucky hire will get:

— A salary between $230,000 and $280,000

— 401(k) with a 4 percent match

— Family medical, dental and vision insurance

— Unlimited time off and 18+ company holidays a year

Who do I contact? Anna Makanju, OpenAI’s head of global affairs and a former adviser to Joe Biden when he was vice president.