United States: Artificial Intelligence In Health Care Delivery: Where Might it Take Us, And What Happens If We Get There?

It is difficult to avoid the specter of "artificial intelligence" (AI) these days, and for those working in the health care sector, there is no exception. Health care delivery has been impacted by a variety of tools that use some form of AI for many years. Further, recent advances in hardware and computer science development have increased the likelihood of even more significant impact. Today, some health diagnostic tools using advanced AI systems in research settings perform as well as their human counterparts, and sometimes better; in the future, performance will continue to improve, and the scope of activities subject to this kind of automation will likely increase.

Currently, advanced AI systems are being used in health care delivery settings in very discrete ways, and are designed to provide practitioners with more and better information with which to make decisions. The function of the practitioner remains unchanged and familiar—the practitioner is the final authority with respect to the provision of diagnostic and treatment service. The practitioner's judgment remains paramount.

It is, therefore, easy to be lulled into a false sense of security regarding the application of legal and regulatory standards with what seems to be nothing more than the addition of another tool in a practitioner's bag. There are, however, reasons to take a more critical view and to consider what the future may hold—because the future and the expanded potential of AI systems in health care deliver is likely not as far away as we might think.

Whose Judgment?

Any professional is held to a standard of care that, at its most fundamental level, recognizes that the professional will exercise his or her judgment in the performance of the profession. That judgment is exercised in the context of past and ongoing learning, training, experience and the utilization of existing tools that assist the professional in exercising that judgment. The professional takes the facts and circumstances and weighs various conclusions regarding a course of action. In this context, AI tools can be extremely beneficial—particularly in the health care context—as they can speed analysis, expand the knowledge base of the provider and speed the review of vast amounts of data.

For liability and licensure purposes, however, the practitioner must never lose sight of his or her own responsibility and always exercise independent judgment. The practitioner must not delegate to the AI system the essential function of being a licensed professional and making the final call. While this may be a simple concept to express, as AI system functionality continues to improve, and expand on their clinical diagnostic and even treatment plan capabilities, it may be a harder concept to implement as time goes on.

Experience indicates that technology will continue in its development as a ubiquitous tool. We accept information technology into our professional and personal lives with ease. Studies indicate that younger generations adopt technology with ease and confidence; and demand that these technologies be made available to them in a variety of contexts. It appears that, unless there is a law against it—and even if there is—someone is going to build an app, and people will use it. The health care sector is not immune to this trend, even though the significant regulatory environment makes rapid and systemically valuable adoption difficult. This pressure for adoption will only increase as AI systems continue to develop, improve and demonstrate their effectiveness in the health care delivery setting.

Clearly, there is nothing wrong with relying on proven technology; but at what point do we, as a society, accept that proven technology can replace the judgment of a licensed professional? If an AI system proves to be more effective and reliable than a human physician at a certain function, then should we not rely on the AI system's judgment?

Oversight and Standards of Care

Regulation is largely about allocating responsibility among actors, and ensuring that certain actors have the requisite skills, knowledge, assets, qualifications or other protections in place given the nature of what they are doing. We regulate health care practitioners, financial institutions, insurers, lawyers, automobile salesmen, private investigators and others because we believe, as a society, that these actors—human or corporate—in exercising their judgment should be held to heightened standards. Accordingly, not only are these actors subject to potentially more exacting standards of care, but also they frequently must be licensed, demonstrate a certain financial stability or otherwise prove a degree of trustworthiness.

Similarly, we hold products to a more exacting standard. In health care in particular, not only do we require medical devices to prove their efficacy and safety, but we also require that their manufacture adhere to certain quality standards. Further, certain products may be held to a standard of "strict liability" if they do not function properly. Accordingly, the developers or manufacturers of these products face significant liability for the failures of their products.

A health care practitioner's standard of care is an evolving standard, and one that does not exclude the appropriate utilization of technology in the care setting—indeed, it may eventually require it if the technology establishes itself in common usage. It is possible to foresee advanced, judgment-rendering AI systems integrated into the care setting. The question we must ask is whether our existing legal and regulatory tools provide an appropriate and effective environment in which these tools are deployed.

Allocating Responsibility

At some point, under some circumstances, AI systems will start to look more like a practitioner than a device—they will be capable of, and we will expect them to, render judgments in a health care context. The AI system will analyze symptoms, data and medical histories and determine treatment plans. In such a circumstance, is it fair to burden the treating practitioner with the liability for the patient's care that is determined by the AI system? Are existing "product liability" standards appropriate for such AI systems?

This latter question is relevant given the "black box" nature of advanced AI systems. The so-called AI "black box" references the difficulty or inability to access the workings of the AI system, as we may otherwise do with other software systems. The reason for this is the nature of some of these AI systems, which are frequently systems that utilize neural networks. In essence, neural networks are large layers of interconnected nodes. The nodes are subject to generally fairly simple functions, but by inputting a great deal of information and "training" the network, these relative unsophisticated interconnected layers of nodes can produce remarkably sophisticated results.

While these neural networks can produce excellent results, their "reasons" for coming up with a conclusion are not easily discernable. In a sense, these new AI systems become functional and effective in a manner similar to the manner a human does. We learn, for example, what a dog is by seeing dogs and being told that these are dogs. The same is true of neural network AI systems. While we may learn later that dogs share common features and are categorized in certain ways, we recognize dogs on the basis of experience; and the same is true for AI systems. Unpacking why an AI system misidentifies a cat as a dog, accordingly, can be very difficult—in essence it is an exercise in understanding why a neural network rendered a judgment.

In this context, it is fair to ask whether a judgment-rendering AI system in any sector should be held to the same standard as other products. We may want to consider any number of factors and actors when determining how to allocate responsibility. We may want to allocate responsibility among the practitioner, the developer of the AI system, the "trainer" of the AI system, the "maintainer" of the AI system and, perhaps, the AI system itself.

How to Regulate: Start Asking the Questions

Achieving a reasonable approach to effectively regulate new dynamics in health care delivery will require thinking carefully about how best to regulate AI systems and care delivery as this technology continues to advance and become capable of taking over certain "professional" functions. A number of factors must be taken into consideration.

1. The existing oversight regime: Right now, the US Food and Drug Administration (FDA) regulates the manufacture and distribution of medical devices, including software, intended to be utilized for the diagnosis, treatment, cure of prevention of disease or other condition. FDA approval or clearance of a medical device does not necessarily limit physician utilization of a product for off-label purposes. State medical boards regulate the practice of medicine, assuring that the physician community is adhering to appropriate standards of care. Both of these regulatory bodies will need to review their approaches to regulation in order to effectively integrate AI systems into care delivery.

2. The ubiquity of AI in the IoT: While some AI systems may be discrete pieces of system machinery, it would be a mistake to ignore AI penetration into the "internet of things" (IoT) and the larger digital landscape, and the related penetration of the IoT into health care through patient engagement, data tracking, wellness and preventative care tools and communication tools. In short, we need to recognize that increasingly sophisticated levels of "health care" are increasingly taking place away from hospitals, doctors' offices and other traditional care settings, and not under the direct supervision of health care professionals.

Directly related to this, of course, is the utilization and maintenance of data. AI health care tools integrated within the IoT will likely be privy to massive amounts of data—but under what approval and subject to what restrictions? Frequently, even the most isolated AI tools in health care rely on massive data sets. Accordingly, data privacy and security issues will increase in importance and consideration of how the existing privacy and security regulatory regime applies to advanced AI systems will necessitate a forward-thinking approach.

3. Liability and insurance: Given the black box nature of AI systems and the unique ways they are developed to perform their functions, determining liability becomes complicated. As noted above, different actors, performing different functions come into play, and the role and function of the health care practitioner may begin to change given the nature of some of these AI systems. The practitioner may take on responsibility for AI system training or testing, for example. How liability should be allocated in such a complex environment is a difficult question, and one that will likely evolve over time.

Further, the standards for liability may need to be reconsidered, and the standards of care for the delivery of care may need to undergo radical transformation in the future if AI systems prove themselves able to function at a higher level of quality than their human counterparts. As the interaction between human physician and AI systems evolve, the standard of care can easily become quite complex and confusing.

4. The robot doctor: Political and legal theorists are already seriously contemplating imbuing AI systems with legal attributes of personhood. While fully sentient and sapient robots may be far off in the future, legal rights and responsibilities do not require such features. For example, we provide corporate bodies and animals with legal rights and responsibilities. We also discriminate among different groups of "people" (e.g., between citizens and non-citizens; between pets and wild animals). In fact, the notion of rights and responsibilities for an AI system may assist in designing an appropriate regulatory environment.

Similarly, we may borrow from human-based liability standards to evaluate whether an AI system caused event is actionable. Given the manner in which neural networks are trained and their black box nature, a "reasonable robot" standard of care may become an effective way in determining whether a wrong has occurred.

The Future of Health Care Professionals

We have not yet reached the age of the machine, and our health care is still best served by rich engagement between patient and well-educated, trained and equipped health care professionals. Health care professionals have the opportunity to shape the way AI systems can best be used in care delivery, and also to shape the way future AI systems can best be utilized in the future as they continue to improve and evolve.

They should take advantage of this opportunity.

The author would like to thank Stephen W. Bernstein, Bernadette M. Broccolo, Shelby Buettner, Jennifer S. Geetter, Vernessa T. Pollard and Erin L. Thimmesch for their comments and suggestions for this article.

Artificial Intelligence In Health Care Delivery: Where Might it Take Us, And What Happens If We Get There?

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.