Regulating Emerging Technology: How Can Regulators Get a Grasp on AI?

By: Chisup Kim

Uses of Artificial Intelligence (“AI”), such as ChatGPT, are fascinating experiments that have the potential to morph their user’s parameters, requests, and questions into answers. However, as malleable these AIs are to user requests, governments and regulators have not had the same flexibility in governing this new technology. Countries have taken drastically different approaches to AI regulations. For example, on April 11, 2023, China announced that AI products developed in China must undergo a security assessment to ensure that content upholds “Chinese socialist values and do[es] not generate content that suggests regime subversion, violence or pornography, or disput[ions to] to economic or social order.” Italy took an even more cautionary stance, outright banning ChatGPT. Yet domestically, in stark contrast to the decisive action taken by other countries, the Biden Administration has only begun vaguely examining whether there should be rules for AI tools.

In the United States, prospective AI regulators seem to be more focused on the application of AI tools to a specific industry. For example, the Equal Employment Opportunity Commission (“EEOC”) has begun an initiative to examine whether AI in employment decisions comply with federal civil rights laws. On autonomous vehicles, while the National Highway Traffic Safety Administration (“NHTSA”) has not yet given autonomous vehicles the green light exemption from occupant safety standards, they do maintain a web page open to a future with automated vehicles. Simultaneously, while regulators are still trying to grasp this technology, AI is entering every industry and field in some capacity. TechCrunch chronicled the various AI applications from Y Combinator’s Winter Demo Day. TechCrunch’s partial list included the following: an AI document editor, SEC-compliance robo-advisors, Generative AI photographer for e-commerce, automated sales emails, an AI receptionist to answer missed calls for small companies, and many more. While the EEOC and NHTSA have taken proactive steps for their own respective fields, we may need a more proactive and overarching approach for the widespread applications of AI. 

Much like their proactive GDPR regulations in privacy, the EU proposed a regulatory framework on AI. The framework proposes a list of high-risk applications for AI, and creates more strenuous obligations for those high-risk applications and tempered regulations for the limited and no risk applications of AI. Applications identified as high-risk include the use of AI in critical infrastructure, education or vocational training, law enforcement, and administration of justice. High-risk applications would require adequate risk assessment and mitigation, logging of data with traceability, and clear notice and information provided to the user. ChatBots are considered limited risk but require that the user has adequate notice that they’re interacting with a machine. Lastly, the vast majority of AI applications are likely to fall under the “no risk” bucket for harmless applications, including applications such as video games or spam filters. 

If U.S. regulators fail to create a comprehensive regulatory framework for AI, they will likely fall behind on this issue, much like they have fallen behind on privacy issues. For example, with privacy, the vacuum of guidance and self-regulating bodies forced many states and foreign countries to begin adopting GDPR-like regulations. The current initiatives by the EEOC and NHTSA are applaudable, but these organizations seem to be waiting for actual harm to occur before taking proactive steps to regulate the industry. For example, last year, NHTSA found that the Tesla autopilot system, among other driver-assisted systems, was linked to nearly 400 crashes in the United States with six fatal accidents. Waiting for the technology to come to us did not work for privacy regulations; we should not wait for AI technology to arrive either.

Are 3D printed human organs a possibility in the near future?

By: Aminat Sanusi

Medically 3D printed human organs have the possibility to save many lives. The United Network for Organ Sharing controls the American transplant system and lists patients in need of an organ transplant. Procedures such as kidney and liver transplants are possible with living donors. But patients on the list for transplants of the heart and lungs are not so lucky. Imagine the infinite possibilities of being able to print a human organ to save a life, instead of waiting until someone died to use theirs? With constant innovation in medicine and the legal field trying to keep up, maybe in this decade or the next, medical trials of 3D printed organs will be a success.

In 2020, the average kidney transplant cost $442,500 and 3D printers cost up to $100,000. The expensive costs of organ transplant surgery come from the transport costs and the actual surgery of implanting the organ. Affordability and insurance coverage issues may arise from time to time but nothing extremely unusual from a normal organ transplant. Nevertheless, accessibility wouldn’t be a huge issue because the organ is created with the patient’s own cells versus a living or non-living organ donor.

What are the current regulations of 3D printed medical devices?

Medical 3D printing has already enhanced treatment for certain medical conditions such as joint replacements and prosthetic limbs. The Food and Drug Administration (FDA) is currently in charge of the regulation of products made and used in the medical field by a 3D printer. The FDA regulates 3D medical devices by categorizing them into groups based on their levels of risk. Regulatory control increases from Class I to Class III, with Class I devices posing the lowest risk to patients. Some requirements apply to the medical devices before they are marketed (premarket requirements), and others apply to the medical devices after they are marketed (postmarket requirements). 

The FDA also regulates the information and application process that the 3D printed medical device seeking acceptance should include. In 2016, the FDA issued a draft guidance to assist manufacturers who are producing medical devices through 3D printing with design, manufacturing, and testing considerations. The guidance categorizes two major topic areas: design and manufacturing considerations which addresses the quality sy draft guidance tstem of the device, and device testing considerations which addresses the type of information that should be included in premarket notification submissions. The FDA continues to evaluate submissions of new 3D printed medical devices to determine its safety and effectiveness.

How are 3D printed organs made?

The possibility of printing 3D human organs is in the near future with organ bioprinting. According to a 2019 medical study, organ bioprinting is the use of 3D printing technologies to assemble multiple cell types, growth factors and biomaterial in a layer-by-layer fashion to produce bioartificial organs that ideally imitate their natural counterparts. The ability to recreate organs with the patient’s own cells is key to avoiding the risk of the patient rejecting the organ or dying before they could be matched with a healthy organ.

Dr. Anthony Atala, the director of the Wake Forest Institute for Regenerative Medicine, and Dr. Jennifer Lewis, a professor at Harvard University’s Wyss Institute for Biologically Inspired Engineering, discuss and explain the process of bioprinting. To begin the process of bioprinting an organ, the doctors need the patient’s cells, so they either choose to do a biopsy of an organ or surgically remove a piece of tissue from the patient’s body. Now the cells need to grow outside of the body, so it’s placed into an incubator that way it’s constantly fed nutrients. Next the cells are mixed with a gel which is similar to glue to create a printable mixture of living cells. Typically the gel is made out of collagen or gelatin. 

For the printing process, the 3D printer is programmed with the patient’s imaging data from X-rays or scans and then loaded with the bioink, which is the gel mixed with the patient’s cells, into the printing chamber to print the organ. Much similar to a regular printer that has cartridges filled with different colored ink, the 3D printer fills up its cartridges with cells. The printing process could take hours to weeks depending on the type of organ that is being printed.

As technological innovation becomes more successful and precise, 3D-printed organ transplants will likely become reality. However, there are current challenges involved with 3D bioprinted organ transplants. The first issue is the functioning of the 3D bioprinted organ is still undergoing testing and trials. The second issue is the uncertainty of how FDA regulations will control the manufacturing and testing of the 3D bioprinted organs. Lastly, the accessibility and affordability of the 3D printed organs is currently limited. 

3D bioprinted organs are created to be complex like a human organ and there are still many challenges to overcome with getting the printed organ to properly function alongside the other human organs in the body. It is still unclear how FDA regulations will be able to control the usage and safety of the product versus the manufacturing and engineering of the product. While there are already procedures in place for 3D printed medical devices like prosthetic limbs which could potentially be applied to bioprinted organs, the regulation of device testing may change because of the use of human cells to print the organs. 

So what comes next?

3D printed medical devices already exist. But why stop there? Why not 3D print human organs? In the award-winning American medical drama television series Grey’s Anatomy, the surgeon 3D printed a part of a human heart and surgically implanted it into the patient. Although the idea of it seems plausible on TV, the reality is a 3D printed human organ has yet to be implanted into a human body. However, that does not mean that 3D printing has not been utilized in the medical field.

The 21st Century Cures Act Will Be Implemented Piecemeal

fdaBy Jason Liu

As technology and medicine advance, the need to streamline and regulate medicine will increase. One can visit a virtual doctor, connect medical devices to the internet, and access cutting-edge gene therapy precision medicine. However, government agencies work with laws that never considered these innovations. To update these laws, the House passed the 21st Century Cures Act in 2015. The Act currently sits in the Health, Education, Labor and Pensions Senate (HELP) committee. Congress may also break the bill into smaller pieces of legislation.

Lamar Alexander (R-Tenn.), the leader of the HELP committee, recently stated that the panel will divide the 21st Century Cures Act into smaller pieces of legislation. The Act has stalled in the Senate because Democrats and Republicans disagree on how to fund the bill. Beginning Feb. 9, the committee will vote on at least seven bipartisan bills ranging from expediting therapies for rare diseases to improving electronic health records. Continue reading

YouTube Remixers & Small Statutory Offenders in Focus

YOUTUBER_ICONBy Andrew H. Fuller

There is little doubt that YouTube content creators have been causing waves in the copyright world since its inception. For example, in 2009, YouTube started to mute the audio tracks of any videos or streams posted by users that contained unauthorized copyrighted music. Another common and popular genre of YouTube content is remixes, where YouTube artists create content by altering and sampling from existing, copyright protected content. Most YouTube content creators are unaware and unconcerned about copyright laws or infringement claims until YouTube cracks down on them. Those who are vaguely familiar often assume that their use is within the bounds of Copyright’s Fair Use exception. Given the general (mis)understanding around Fair Use and the courts’ treatment and application of this exception, the Lanham Act would seem ripe for an update. While the technological landscape of media dissemination and user consumption has radically shifted, the laws around copyright haven’t changed. Continue reading

Are Hoverboards Hovering Above the Law?

hoverboardBy Denise Kim

Hoverboard, glider, electric skateboard, or skywalker—the technology goes by many different names. But many in the public and the news use the term hoverboard. For those who are unfamiliar with the technology, a hoverboard is a self-balancing scooter or a two-wheeled motorized gadget that normally costs between $300-500. To operate a hoverboard, the owner leans forward to move ahead. The owner leans back on the two pressure sensitive footpads to brake or reverse. Hoverboards have become a new staple in the 21st Century. Hoverboards have also raised safety concerns.

One safety concern is that hoverboards can randomly catch on fire. Major airlines including American, Delta, United and Southwest banned hoverboards from being checked in or carried on the plane. Toward the end of 2015, these safety concerns caused major panic across the U.S. and the rest of the world as many bought hoverboards for loved ones for Christmas. The airline companies cited concerns over the lithium ion batteries (which the Federal Aviation Administration regulates as hazardous materials) as the reason behind this universal ban. Continue reading