Regulations on AI for healthcare workers and nurses

The regulation of AI in healthcare, particularly related to the roles of healthcare workers and nurses, is a complex and changing field. As AI advances and integrates more deeply into healthcare systems, the regulation will undoubtedly continue to develop.

The challenge for regulators, healthcare providers, and technology developers is to create a framework that ensures patient safety, protects the roles of healthcare workers, promotes innovation, and addresses the ethical implications of AI in healthcare. This will require ongoing dialogue, flexibility, and a commitment to putting patient care at the center of all regulatory efforts.

The current regulatory landscape

Federal level initiatives

As of 2024, the United States lacks a federal law specifically regulating AI in healthcare. However, this absence doesn't indicate a lack of concern or action at the federal level. Lawmakers and regulatory bodies are increasingly aware of the need for guidance.

One piece of legislation that touches on AI in healthcare is the Pandemic and All-Hazards Preparedness and Response Act (S2333), introduced in July 2023. While not exclusively focused on AI, this act recognizes the potential impact of AI on health security. It mandates a thorough study on the vulnerabilities that AI might introduce to health security systems. Furthermore, it requires a detailed report outlining actions to mitigate risks associated with the misuse of AI in health security contexts.

The Food and Drug Administration (FDA) has also been proactive in addressing AI in medical devices. In 2021, the FDA released an action plan for AI/ML-based Software as a Medical Device (SaMD). The plan outlines a multi-pronged approach to advance the agency's oversight of AI-based medical software. While not directly regulating AI healthcare workers, these guidelines set a precedent for how AI systems in healthcare might be evaluated and regulated in the future.

State-level regulations

At the state level, we see a more diverse and active regulatory environment, with several states taking the lead in addressing AI in healthcare:

• Virginia's HB2154: Effective since March 18, 2021, this law is one of the first to directly address AI in healthcare settings. It requires hospitals, nursing homes, and certified nursing facilities to implement policies regarding the use of intelligent personal assistants provided by patients. The law recognizes the increasing prevalence of AI-powered devices in healthcare settings and tries to ensure their appropriate use.
• Illinois Safe Patients Limit Act (SB2795): Initially introduced in 2023 and reintroduced in January 2024, this act goes beyond mere regulation of AI devices. It tries to set limits on patient assignments to registered nurses, directly addressing the potential impact of AI on nursing workloads. It also prohibits policies that would substitute independent nursing judgments with AI-driven decisions. The act reflects growing concerns about the potential displacement of human decision-making in critical care situations.
• Georgia's HB887: Introduced in January 2024, this bill takes a strong stance on AI in healthcare decision-making. It prohibits insurance coverage decisions from being based solely on AI algorithms, mandating meaningful human review of AI-assisted healthcare decisions. The legislation maintains mandatory human oversight in healthcare processes, even as AI becomes more sophisticated.
• Massachusetts H1974: The proposed legislation focuses on the use of AI in mental health services, an area where the personal touch of human providers is often considered imperative. The bill requires approval from licensing boards for the use of AI in mental health treatment and mandates patient disclosure and consent for AI-assisted treatment. The approach recognizes the sensitive nature of mental health care and seeks to ensure that AI is used ethically and transparently in this field.

In the news: WHO identifies 6 focus areas for AI regulation in healthcare 

Regulatory concerns

The integration of AI into healthcare roles traditionally filled by nurses and other healthcare workers raises several concerns:

• Patient safety: At the forefront of regulatory concerns is ensuring that AI systems do not compromise the quality of patient care. This includes safeguarding against errors in AI-driven diagnoses or treatment recommendations, as well as ensuring that AI systems can handle complex, nuanced medical situations that may require human intuition and experience.
• Privacy and data protection: AI systems in healthcare often require access to vast amounts of sensitive patient data. Regulators are concerned with how this data is collected, stored, and used. Ensuring compliance with existing privacy laws like HIPAA while allowing for the data access necessary for AI systems to function effectively is a challenge.
• Accountability and liability: As AI systems take on more decision-making roles in healthcare, questions of accountability become more complex. Who is liable when an AI system makes a mistake – the healthcare provider, the AI developer, or the institution implementing the AI? Regulators are working to establish clear lines of responsibility and liability frameworks.
• Transparency and explainability: Many AI systems, particularly those using deep learning, operate as "black boxes," making it difficult to understand how they arrive at their conclusions. Regulators are increasingly calling for AI systems in healthcare to be transparent and explainable, allowing healthcare providers and patients to understand the basis for AI-driven decisions.
• Human oversight and the role of healthcare workers: There's a growing consensus that AI should augment rather than replace human healthcare workers. Regulators are looking at ways to ensure meaningful human oversight of AI systems and to protect the roles of nurses and other healthcare professionals.
• Equity and bias: AI systems can potentially perpetuate or even exacerbate existing biases in healthcare. Regulators are concerned with ensuring that AI systems are developed and implemented in ways that promote equity and do not discriminate against certain patient populations.

Read more: Using AI for HIPAA compliance 

Nursing perspectives on AI regulation

The nursing community has been particularly vocal about the need for careful regulation of AI in healthcare. Perspectives from the nursing field include:

• Preserving nursing judgment: Nurses stress maintaining human judgment in patient care. They argue that while AI can be a valuable tool, it should not replace the critical thinking and empathy that nurses bring to patient care.
• Education and training: There's a growing call for nursing education to include training on AI technologies. Nurses argue that they need to understand how AI works to effectively use it as a tool and to advocate for its appropriate use in patient care.
• Input in policy development: Nursing organizations are pushing for greater involvement of nurses in the development of AI policies and regulations. They argue that as frontline care providers, nurses have unique insights into how AI can best be integrated into healthcare settings.
• Workload and staffing concerns: Some nurses worry that AI might be used to justify reduced staffing levels. They advocate for regulations that ensure AI is used to support nurses rather than replace them.
• Ethical considerations: Nurses are at the forefront of discussions about the ethical implications of AI in healthcare. They raise questions about how AI might impact the nurse-patient relationship and the potential for AI to dehumanize aspects of healthcare.

Read also: Artificial Intelligence in healthcare 

In the news

The WHO's recent report, “Regulatory considerations on artificial intelligence for health”

discusses regulating AI in healthcare. It brings to attention the broader challenges and potential risks associated with AI in various sectors, including ethical concerns, data privacy, and the amplification of biases. As the WHO identifies main focus areas like transparency, risk management, data quality, and privacy protection in healthcare AI, it brings to attention the need for oversight in all AI applications. The involved companies are required to respond within 45 days of receiving the order, marking a major moment in the regulation and oversight of the AI sector.

See more: WHO releases publication outlining considerations for AI in healthcare

FAQs

What role will international regulations play?

The EU's AI Act could serve as a model for other countries, including the U.S.

Will healthcare-specific AI regulations emerge?

Yes, regulations tailored to healthcare AI may be developed in a way similar to medical device regulations.

What is adaptive regulation?

It refers to flexible frameworks that can change as AI technologies do.

How will collaboration shape AI regulations?

Policymakers, healthcare providers, AI developers, and patient groups will likely work together on future regulations.

What ethical concerns will impact AI regulations?

AI systems will need to align with established medical ethics principles.

Will new oversight bodies be created for AI in healthcare?

Yes, we might see new agencies or expanded roles for existing ones to oversee AI.