Introduction
Artificial Intelligence (“AI”) has emerged as a game-changer in the rapidly evolving healthcare landscape, revolutionizing how we approach diagnosis, treatment, and patient care. However, this transformative journey is not without its challenges, as AI systems lack regulations, raising concerns about the responsible development and deployment of AI in the healthcare sector. The lack of AI regulations may increase the likelihood of unsafe or harmful practices and compromise patient privacy. Accordingly, it is critical to regulate the development of AI technology and assess any associated risks.
In 2023, 25 states, Puerto Rico, and the District of Columbia introduced AI bills in an effort to regulate AI development and use.[1] Roughly 18 states and Puerto Rico adopted resolutions or enacted legislation that included creating agencies to assess AI use.[2] Most states do not yet regulate AI, which will be necessary to increase a general understanding of its potential consequences. A central concern for the unregulated use of AI is the possibility of systemic bias against protected classes. Some states like Massachusetts, Rhode Island, and the District of Columbia have proposed legislation to reduce societal discrimination resulting from AI and its decision-making tools.[3]
AI advancements in healthcare
AI algorithms have tremendously influenced technological advancements—such as data-processing capabilities and robot-assisted surgical procedures—and will continue to shape our future. With responsible use and development, healthcare treatment can focus on a more preventative approach, such as using data and personalized treatments to improve patient outcomes. Generally, in the healthcare industry, AI technology is used in radiology, patient screening, psychiatry, primary care, disease diagnoses, and telemedicine.[4] Some of the most advanced algorithms analyze DNA to diagnose and treat diseases. Some AI models can even analyze MRI results to screen for cancer.[5]
Additionally, with the help of AI, treatment plans can be tailored to individual patients based on their unique genetic makeup, lifestyle, and medical history. Precision medicine is a phrase used to describe specialized treatment for patients depending on their genes, behaviors, and environment. This personalized approach enhances treatment efficacy and minimizes adverse effects, optimizing the patient’s experience. Overall, AI integration in healthcare is expected to improve precision medicine and increase accessibility to this type of treatment.
Potential issues
Despite the extensive regulations in the healthcare sector, no regulations target AI use in medical devices.[6] The current regulatory framework merely serves as a non-binding recommendation. Unregulated rapid advancements in AI technology leave a void that raises ethical, legal, and privacy concerns.[7] Additionally, the development of AI can lead to bias in algorithms and overreliance on technology. Problems arise when algorithms inadvertently reflect existing biases in healthcare data, leading to disparities in diagnoses and treatment. Systemic biases are present in various forms within healthcare, including the lack of standardized data and accountability measures regarding race and ethnicity.
Another concern for using AI in healthcare is the vulnerability of sensitive patient data. “Healthcare entities and their third-party vendors are particularly vulnerable to data breaches and ransomware attacks.”[8] Developing and training AI algorithms requires plenty of patient data, which becomes vulnerable to cyberattacks or data misuse. There is often a lack of transparency regarding the use of patient data, which may implicate issues surrounding informed consent.[9] Inputting accurate patient data into AI algorithms will likely lead to more effective treatment because providers can use the data to implement more preventive treatments instead of responsive treatments. Nonetheless, providers should be required to inform their patients about how AI works and its role in developing treatment plans so that patients can assess the risk of beginning treatment plans developed by AI.
Recommendations for AI regulations
In October 2023, President Biden issued an Executive Order to ensure the safe use of AI in the United States.[10] This Order established regulations for AI’s safe, secure, and trustworthy development that apply across various industries in the United States. Among other regulations, this order requires the U.S. Department of Health and Human Services to publish a plan to address the implementation and use of algorithmic systems and establish an AI Task Force to ensure strategic, responsible use. AI developers must now share their safety test results and critical information with the U.S. government.[11] The Executive Order mainly serves as guidance for institutions and agencies and is the first step in encouraging uniform regulation throughout the U.S.[12]
More stringent regulation for the use of AI is needed before reaping the potential benefits in the healthcare sector. With federal regulations, our society can avoid overlooking AI’s potential harm because of its rapid development. When developing AI technology, the focus should equally be on the risks associated with creating new technology and exploring potential benefits. For example, data collection methods should be reassessed to ensure increased accuracy in patient treatment. To create an additional safeguard, data used for the training and development of algorithms should be validated by a third party. With calculated safeguards, we can encourage the safe use of AI and responsible development of new technology in the healthcare sector.
Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHBL or Suffolk University Law School.
Luis Gutierrez, Class of 2025 was born and raised in Chicago, IL, and graduated from the University of Illinois with a bachelor’s degree in criminology, law, and justice. Luis is interested in healthcare, business, and real estate law.
[1] See Artificial Technology 2023 Legislation, Nat’l Conf. of State Legislatures (Jan. 12, 2024), https://www.ncsl.org/technology-and-communication/artificial-intelligence-2023-legislation [https://perma.cc/8C96-5VVF].
[2] See id.
[3] See States Take the Lead on Regulation Artificial Intelligence, Brennan Ctr. for Just. (Nov. 6, 2023), https://www.brennancenter.org/our-work/research-reports/states-take-lead-regulating-artificial-intelligence [https://perma.cc/LX22-7MMB].
[4] See The Evolution Of AI In Healthcare, Xsolis, https://www.xsolis.com/blog/the-evolution-of-ai-in-healthcare/ [https://perma.cc/LNX8-2BYZ].
[5] See Can Artificial Intelligence Help See Cancer in New, and Better Ways?, Nat’l Cancer Inst. (Mar. 22, 2022), https://www.cancer.gov/news-events/cancer-currents-blog/2022/artificial-intelligence-cancer-imaging [https://perma.cc/NHP8-RRMY].
[6] See Regulating AI in healthcare: Fall 2023 observations — Part one, Infermedica (Sep. 22, 2023),
https://infermedica.com/blog/articles/regulating-ai-in-healthcare-fall-2023-observations-part-one [https://perma.cc/94GM-4M79].
[7] See id.
[8] See Understanding the advantages and risks of AI usage in healthcare, Thomson Reuters (Sep. 27, 2023), https://www.thomsonreuters.com/en-us/posts/technology/ai-usage-healthcare/#:~:text=In%20some%20instances%2C%20the%20AI,data%20breaches%20and%20ransomware%20attacks. [https://perma.cc/CLR5-B3T2].
[9] See Lawmakers stress data privacy in health AI oversight, Healthcare Dive (Nov. 30, 2023), https://www.healthcaredive.com/news/healthcare-ai-data-privacy-house-energy-commerce-subcommittee/701126/#:~:text=The%20growing%20role%20of%20artificial%20intelligence%20in%20healthcare,-Amid%20mounting%20interest&text=Data%20privacy%20%E2%80%94%20already%20a%20challenge,Frank%20Pallone%2C%20D%2DN. [https://perma.cc/MMV4-JWGR].
[10] See FACT SHEET: President Biden Issues Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence, The White House (Oct. 30, 2023), https://www.whitehouse.gov/briefing-room/statements-releases/2023/10/30/fact-sheet-president-biden-issues-executive-order-on-safe-secure-and-trustworthy-artificial-intelligence/ [https://perma.cc/5A99-CUC3].
[11] See id.
[12] See How Will Biden’s Executive Order on Trustworthy AI Impact Healthcare?, TechTarget (Dec. 20, 2023), https://healthitanalytics.com/features/how-will-bidens-executive-order-on-trustworthy-ai-impact-healthcare [https://perma.cc/DH6N-PVE5].