The healthcare industry is heavily regulated, from the licensing of doctors to equipment standards to clinical trials for new medicines. AI/SaMD represents a further expansion of the regulated industry. However, they also bring with them unique challenges that must be managed. This can include inaccurate diagnosis risk, misuse of data or bias in algorithms.

Excellus Health is an American health insurance company that recently encountered several ethical and legal issues surrounding artificial intelligence in medical settings. The question is: Who should be responsible for issues such as patient privacy, accountability, and sharing of liability when systems fail?

Legal regulations are still a barrier for SaMD and AI technologies in healthcare. Regulation bodies must establish guidelines to ensure that these technologies are efficient, safe, and secure. Until this happens, the regulatory risk is elevated, and companies need to take proactive measures to reduce it.

There are already solutions available for medical software and technology providers to reduce the risk of failure to comply with legal standards. These tools, which are based on data-driven methods, allow them to create legally compliant products faster while reducing the time and resources required to comply with evolving governmental privacy standards. This article aims to explore the sources of legal regulation of medical applications of AI and the mechanisms for establishing its liability.

Legal Analysis of Regulations

The healthcare sector is one of the most heavily regulated on the planet, from doctors requiring licenses to equipment standards and rigorous clinical trials for new drugs. With the promise of AI, there are many new opportunities to decrease healthcare costs and manage patient care more effectively. However, this opportunity is complicated by the need to ensure that AI products are safe and reliable, that patients and physicians can trust these technologies, and that privacy and security issues are addressed.

As the adoption of healthcare AI accelerates, it is important that law and regulation keep pace with this dynamic technology. Regulatory efforts to address the legal issues associated with healthcare AI are currently underway, but they will require continued vigilance and innovation in order to ensure that this promising technology is not hampered by outdated laws and regulations.

For example, determining what constitutes de-identification of medical data will vary by jurisdiction. This is because some data is protected by various privacy laws, such as HIPAA in the U.S. and the Russian Federation’s Federal Law 323-FZ of 21 November 2011 [61] “On Personal Data”. In addition, some medical records contain data that cannot be automatically de-identified because of specific information contained in those records, such as physician names, addresses or phone numbers. In these cases, the process of de-identification may need to include a human review of the information in order to determine whether the data can be considered anonymous and therefore suitable for use in an artificial intelligence system.

It is also important that the companies that develop and provide healthcare AI be prepared to respond to regulator and consumer inquiries with clear, accurate and detailed explanations of the logic underlying an AI-based product or service. This includes ensuring that the company is ready to document the underlying models and demonstrate that its products are not biased. Additionally, new proposals for privacy laws in Colorado and California would require companies to include AI-specific transparency provisions in their privacy policies that detail the high-impact decisions made by an AI product.

It is important that laws and regulations allow for the apportionment of damages caused by the malfunction or failure of an AI-enabled device or recommendation. Product liability laws currently only cover defective medical devices and equipment, but not SaMD or AI algorithms.

It is important that laws and regulations allow for the apportionment of damages caused by the malfunction or failure of an AI-enabled device or recommendation.

Legal Analysis of Data

As technology evolves faster than the law, it is essential that regulators keep up with trends to ensure that digital health innovations comply with applicable laws and regulations. AI is no exception. Whether it is a legal tool or a clinical tool, the technology must be carefully tested and vetted to make sure that it is safe, effective, and ethical.

AI has been used in a wide range of legal applications, including e-discovery, contract review, and document analysis. Its use is expected to expand rapidly in the near future, especially in the healthcare sector. This technology will require a significant investment of time and resources by legal teams to ensure that it operates properly.

Using AI for healthcare requires the collection of vast amounts of patient data to train the algorithms. Such data may contain sensitive information and privacy issues. Therefore, data sharing will need to be regulated. Currently, healthcare organizations are considered the owners of patient data and must obtain informed consent before they can share it with others.

It is also critical to consider how the data will be analyzed and what it will be used for. For example, some legal analytics software claims that it can analyze and interpret case documents and docket entries to provide supplementary insights to lawyers during litigation. This type of software was recently used by an intellectual property attorney who represented a generic pharmaceutical company. It helped her to identify the judge’s history of ruling cases similar to her client’s, and this knowledge helped her to resolve the matter more quickly.

Other important considerations include the risk of bias in an AI system, and how that will be handled by a legal system. Bias occurs when an algorithm is trained with data that does not represent a diverse population, leading to results that are biased toward certain groups. This problem could become more serious when an AI system is used in a medical setting, where the outcomes of its decisions can have profound consequences for patients’ lives. It is vital that laws and regulatory frameworks consider how to handle these risks, which should be considered in the context of physician-patient confidentiality and the oath of “primum non nocere” (first, do no harm).

Legal Analysis of Algorithms

With the help of big data and powerful machine learning techniques, innovators are developing tools to improve clinical care, advance medical research, and increase efficiency in the healthcare industry. These tools rely on algorithms, programs created from healthcare data that can make predictions and recommendations. However, the inner workings of many algorithms are too complex to understand or even describe. This makes them black boxes, which can create liability issues if the AI fails to perform as expected or causes any harm.

As a result, legal analysis tools have been developed to examine the potential impact of new technologies and assess their risks. These tools are especially useful for legal professionals preparing for litigation or searching for new sources of evidence. For example, Bloomberg Law’s Points of Law feature uses supervised machine learning to extract and identify key information from court opinions and documents to help lawyers efficiently conduct legal research. This can reduce the amount of time attorneys spend on manual discovery tasks and free up resources to focus on strategic work.

Although the COVID-19 crisis has accelerated ongoing digital healthcare trends, the regulation of AI is still developing around the world. Some countries have begun to implement laws and regulations regarding ownership and control of data, privacy protection, telemedicine, and accountability. However, these laws will likely need to be updated as AI technologies evolve and expand.

Some concerns surrounding the use of AI in healthcare include data security, attribution of liability in case of a malfunctioning algorithm, and a lack of transparency about how the algorithms are trained. The latter issue is particularly important because the development and application of AI technology requires extensive data collection, which can raise issues about privacy and fairness.

In addition, the reliance on data can lead to bias in the results of the system. For example, if an ML model is trained using data from criminal justice systems that are disproportionately slanted against certain populations, it may enshrining these injustices in its decisions and creating a false sense of objectivity.

For these reasons, it’s important for policymakers and legal practitioners to consider the legal implications of AI-based healthcare. Scholars across multiple disciplines are articulating concerns that require legal responses to ensure the appropriate balance is struck.

Legal Analysis of Patient Data

The healthcare industry is one of the most highly regulated in the world, from doctors requiring licenses to equipment standards and rigorous clinical trials for new drugs. AI is changing all that, but the pace of innovation makes it hard for regulators to keep up. It is therefore vital that legal systems also keep up, which raises some interesting questions about liability for AI-based decisions.

While medical innovations offer tremendous hope, they must be accompanied by equally innovative governance reforms in order to realize their benefits and avoid their potential pitfalls. It is therefore important to understand the legal implications of healthcare AI, particularly when it comes to data protection and accountability.

Modern medicine is strongly characterized by multidisciplinary teams, and this has been a great boon for patient care. However, it is also not without its unique drawbacks, including miscommunication and a focus on the physician’s particular area of expertise to the detriment of a more holistic evaluation of patients’ cases.

AI can help to address these issues, as it can provide a more objective evaluation of patients and their condition, removing some of the human biases inherent in traditional medicine. However, it is essential to ensure that any medical decision made by AI is transparently explained and backed up by reliable evidence, so that the legal system can assess its validity and reliability in court.

As the use of healthcare AI becomes increasingly common, it is likely that more lawsuits will be filed against companies whose algorithms are used by hospitals and other healthcare organizations. These cases may involve claims of malpractice, negligence or product liability. While it is generally understood that product liability applies to defective medical devices, it may be less clear how to assign liability when AI-enabled software makes errors that lead to injury or death.

It is also possible that AI could violate privacy laws, causing serious problems for patients and companies using the technology. This is particularly the case if the data being used to train AI is personal health information. While this is a legitimate concern, it may be mitigated by making sure that the data being used is anonymized or pseudo-anonymized before it is uploaded to an AI database. Privacy and ethical concerns are paramount when using AI for legal analysis in healthcare settings. Here are a few key considerations.

a. Privacy of Patient Data

Healthcare data is sensitive and subject to strict privacy regulations such as the Health Insurance Portability and Accountability Act in the United States, or the General Data Protection Regulation in Europe. AI systems should be designed in a way that ensures the highest level of protection for patient data. It includes strong encryption, access control, and data anonymization.

b. Informed Consent 

When AI is used in healthcare for legal analysis, patients and other individuals should be informed of how their data will be used and provide informed consent. Transparent communication is essential to maintain trust.

c. Data Ownership

 It is important to clarify who controls and owns the healthcare data that’s used for legal analyses. Patients should be able to have their say on how data is used and shared, and should also be informed of the purpose for which they are being used.

d. Fairness and Bias

AI can inherit biases from the data that they are trained with. These biases in healthcare can lead to disparities between patient care. To ensure fairness, it is important to audit and evaluate AI algorithms regularly for bias.

e. Accountability and Transparency

Some AI algorithms are black boxes, making it difficult to understand the decision-making process. Transparency in AI is becoming more and more important to address this issue. Developers must document their models, and explain the decisions they make.

f. Human oversight

AI can help in legal analysis but it shouldn’t replace human judgement entirely. It is important to have human oversight in order to make sure that ethical issues and subtleties are not missed.

AI can help in legal analysis but it shouldn't replace human judgement entirely.

g. Security

AI-based systems that are used for legal analysis must have strong security measures to prevent unauthorized access or data breaches. It is important to protect against cyber-attacks and ensure data integrity.

h. Minimization Data Collection

Only essential data should be collected for legal analysis. According to the principle of data minimization, organizations should only collect relevant and essential data for their intended purpose.

The potential long-term effects of AI should be considered when using it in legal healthcare analysis. What will happen with the data after the analysis? There should be clear policies in place.

i. Compliance, Continuous Monitoring, and Auditing

Regular auditing and monitoring of AI systems is necessary to ensure compliance and ethical usage. It is important to conduct periodic assessments on how patient data are handled. Adherence is not negotiable. AI systems used in healthcare are required to comply with regulations such as HIPAA or GDPR.

j. Ethical frameworks

Organizations must develop and adhere to ethical frameworks for the use of AI within healthcare legal analysis. These frameworks must align with societal value and put the well-being of patients first.

The responsible use of AI for legal analysis in the healthcare sector requires a holistic, integrated approach that includes ethical considerations, privacy, transparency and ongoing supervision. While maximizing the benefits of AI for healthcare regulation analysis, it is important that organizations and developers prioritize the rights and welfare of individuals and patients.