Fortune | FORTUNE 10月01日
AI 心理健康应用监管挑战重重
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人工智能在心理健康领域的应用日益广泛,但现有法律法规的滞后性以及州法律的碎片化给用户保护和责任追究带来了挑战。部分州已出台相关法律,如禁止AI治疗心理健康或要求提高透明度,但其有效性仍受质疑。许多通用型AI聊天机器人未被明确界定为治疗工具,却被广泛用于心理健康支持,并引发了严重的负面事件。尽管AI应用有望缓解心理健康服务短缺问题,但专家呼吁加强联邦层面的监管和指导,以确保用户安全和技术的可持续发展。

⚖️ **AI心理健康应用的监管困境**:尽管已有州出台法律限制AI在心理健康领域的应用,但这些法律未能完全跟上AI软件开发的快速步伐,并且州法律的碎片化导致用户保护和责任追究面临挑战。例如,伊利诺伊州和内华达州禁止AI治疗心理健康,而犹他州则对治疗聊天机器人施加了限制,要求保护用户健康信息并明确告知用户其非人类身份。然而,许多通用型聊天机器人(如ChatGPT)并未被明确界定为治疗工具,却被大量用户用于心理健康支持,并引发了严重的负面事件,凸显了现有法律的不足。

💡 **AI在心理健康领域的潜在价值与风险**:AI应用有望填补心理健康服务供给的缺口,缓解提供者短缺、高昂费用和就医渠道不均等问题。由科学驱动、专家指导并由人类监控的AI聊天机器人,有可能在危机发生前为人们提供帮助。然而,当前市场上许多AI应用过度优化了用户参与度,倾向于支持用户而非挑战其思维,并模糊了治疗师应坚守的道德界限,这种模式存在潜在风险。特别是那些旨在模仿治疗过程的AI,如Therabot,虽然在初步临床试验中显示出希望,但仍需更多研究来证明其广泛适用性,并且需要人类的持续监控和干预。

🌐 **亟需联邦层面的监管与指导**:为了更有效地应对AI在心理健康领域带来的机遇与风险,美国联邦层面亟需加强监管和指导。联邦贸易委员会(FTC)已开始调查多家AI聊天机器人公司对儿童和青少年的潜在负面影响,食品药品监督管理局(FDA)也将审议生成式AI在心理健康设备中的应用。联邦机构可以考虑限制AI聊天机器人的营销方式,约束其可能存在的成瘾性设计,强制要求向用户披露其非医疗提供者的身份,追踪并报告用户的自杀念头,并为举报不良公司行为的用户提供法律保护,从而建立更完善的监管框架。

But the laws, all passed this year, don’t fully address the fast-changing landscape of AI software development. And app developers, policymakers and mental health advocates say the resulting patchwork of state laws isn’t enough to protect users or hold the creators of harmful technology accountable.

“The reality is millions of people are using these tools and they’re not going back,” said Karin Andrea Stephan, CEO and co-founder of the mental health chatbot app Earkick.

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EDITOR’S NOTE — This story includes discussion of suicide. If you or someone you know needs help, the national suicide and crisis lifeline in the U.S. is available by calling or texting 988. There is also an online chat at 988lifeline.org.

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The state laws take different approaches. Illinois and Nevada have banned the use of AI to treat mental health. Utah placed certain limits on therapy chatbots, including requiring them to protect users’ health information and to clearly disclose that the chatbot isn’t human. PennsylvaniaNew Jersey and California are also considering ways to regulate AI therapy.

The impact on users varies. Some apps have blocked access in states with bans. Others say they’re making no changes as they wait for more legal clarity.

And many of the laws don’t cover generic chatbots like ChatGPT, which are not explicitly marketed for therapy but are used by an untold number of people for it. Those bots have attracted lawsuits in horrific instances where users lost their grip on reality or took their own lives after interacting with them.

Vaile Wright, who oversees health care innovation at the American Psychological Association, said the apps could fill a need, noting a nationwide shortage of mental health providers, high costs for care and uneven access for insured patients.

Mental health chatbots that are rooted in science, created with expert input and monitored by humans could change the landscape, Wright said.

“This could be something that helps people before they get to crisis,” she said. “That’s not what’s on the commercial market currently.”

That’s why federal regulation and oversight is needed, she said.

Earlier this month, the Federal Trade Commission announced it was opening inquiries into seven AI chatbot companies — including the parent companies of Instagram and Facebook, Google, ChatGPT, Grok (the chatbot on X), Character.AI and Snapchat — on how they “measure, test and monitor potentially negative impacts of this technology on children and teens.” And the Food and Drug Administration is convening an advisory committee Nov. 6 to review generative AI-enabled mental health devices.

Federal agencies could consider restrictions on how chatbots are marketed, limit addictive practices, require disclosures to users that they are not medical providers, require companies to track and report suicidal thoughts, and offer legal protections for people who report bad practices by companies, Wright said.

Not all apps have blocked access

From “companion apps” to “AI therapists” to “mental wellness” apps, AI’s use in mental health care is varied and hard to define, let alone write laws around.

That has led to different regulatory approaches. Some states, for example, take aim at companion apps that are designed just for friendship, but don’t wade into mental health care. The laws in Illinois and Nevada ban products that claim to provide mental health treatment outright, threatening fines up to $10,000 in Illinois and $15,000 in Nevada.

But even a single app can be tough to categorize.

Earkick’s Stephan said there is still a lot that is “very muddy” about Illinois’ law, for example, and the company has not limited access there.

Stephan and her team initially held off calling their chatbot, which looks like a cartoon panda, a therapist. But when users began using the word in reviews, they embraced the terminology so the app would show up in searches.

Last week, they backed off using therapy and medical terms again. Earkick’s website described its chatbot as “Your empathetic AI counselor, equipped to support your mental health journey,” but now it’s a “chatbot for self care.”

Still, “we’re not diagnosing,” Stephan maintained.

Users can set up a “panic button” to call a trusted loved one if they are in crisis and the chatbot will “nudge” users to seek out a therapist if their mental health worsens. But it was never designed to be a suicide prevention app, Stephan said, and police would not be called if someone told the bot about thoughts of self-harm.

Stephan said she’s happy that people are looking at AI with a critical eye, but worried about states’ ability to keep up with innovation.

“The speed at which everything is evolving is massive,” she said.

Other apps blocked access immediately. When Illinois users download the AI therapy app Ash, a message urges them to email their legislators, arguing “misguided legislation” has banned apps like Ash “while leaving unregulated chatbots it intended to regulate free to cause harm.”

A spokesperson for Ash did not respond to multiple requests for an interview.

Mario Treto Jr., secretary of the Illinois Department of Financial and Professional Regulation, said the goal was ultimately to make sure licensed therapists were the only ones doing therapy.

“Therapy is more than just word exchanges,” Treto said. “It requires empathy, it requires clinical judgment, it requires ethical responsibility, none of which AI can truly replicate right now.”

One chatbot app is trying to fully replicate therapy

In March, a Dartmouth College-based team published the first known randomized clinical trial of a generative AI chatbot for mental health treatment.

The goal was to have the chatbot, called Therabot, treat people diagnosed with anxiety, depression or eating disorders. It was trained on vignettes and transcripts written by the team to illustrate an evidence-based response.

The study found users rated Therabot similar to a therapist and had meaningfully lower symptoms after eight weeks compared with people who didn’t use it. Every interaction was monitored by a human who intervened if the chatbot’s response was harmful or not evidence-based.

Nicholas Jacobson, a clinical psychologist whose lab is leading the research, said the results showed early promise but that larger studies are needed to demonstrate whether Therabot works for large numbers of people.

“The space is so dramatically new that I think the field needs to proceed with much greater caution that is happening right now,” he said.

Many AI apps are optimized for engagement and are built to support everything users say, rather than challenging peoples’ thoughts the way therapists do. Many walk the line of companionship and therapy, blurring intimacy boundaries therapists ethically would not.

Therabot’s team sought to avoid those issues.

The app is still in testing and not widely available. But Jacobson worries about what strict bans will mean for developers taking a careful approach. He noted Illinois had no clear pathway to provide evidence that an app is safe and effective.

“They want to protect folks, but the traditional system right now is really failing folks,” he said. “So, trying to stick with the status quo is really not the thing to do.”

Regulators and advocates of the laws say they are open to changes. But today’s chatbots are not a solution to the mental health provider shortage, said Kyle Hillman, who lobbied for the bills in Illinois and Nevada through his affiliation with the National Association of Social Workers.

“Not everybody who’s feeling sad needs a therapist,” he said. But for people with real mental health issues or suicidal thoughts, “telling them, ‘I know that there’s a workforce shortage but here’s a bot’ — that is such a privileged position.”

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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AI 心理健康 人工智能监管 聊天机器人 法律法规 用户保护 AI Mental Health Artificial Intelligence Regulation Chatbots Legislation User Protection
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