Dorsey Health Law
Artificial Intelligence
AI and Healthcare: More Guidance and Regulations are Coming to Town
There is no doubt that artificial intelligence (“AI”) and more specifically, generative AI, is one of the hottest topics in healthcare for 2023. There is also no doubt that it will continue to be a hot topic into 2024 and beyond as healthcare providers and patients have greater access to generative AI and learn how to use it within the world of healthcare. On October 30, 2023, the Biden Administration took another step toward addressing AI by issuing an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (available here). The Executive Order follows an October 2022 blueprint for an AI Bill of Rights, which was intended to outline principles “that should guide the design, use, and deployment of automated systems to protect the American public in the age of artificial intelligence.” The AI Bill of Rights Blueprint is available here. The Executive Order confirms that the Biden Administration recognizes the potential of AI to “solve urgent challenges while making our world more prosperous, productive, innovative, and secure”. However, the Administration also recognizes that “irresponsible use could exacerbate societal harms such as fraud, discrimination, bias, and disinformation; displace and disempower workers, stifle competition; and pose risks to national security.” With these issues in mind, the Executive Order sets forth eight principles: AI must be safe and secure. Promoting responsible innovation, competition and collaboration will allow the United States to lead in AI and unlock its potential to solve some of society’s most difficult challenges. Responsible development and use of AI requires a commitment to supporting American workers. AI policies must be consistent with the advancement of equity and civil rights. The Executive Order specifically mentions that healthcare, in particular, is an area where AI can deepen discrimination and bias. The interests of Americans who increasingly use, interact with, or purchase AI and AI-enabled products in daily life must be protected. The Executive Order notes that this is critical in fields such as healthcare. Americans’ privacy and civil liberties must be protected. The federal government must manage risks in its own use of AI and increase internal capacity to regulate, govern and support responsible use of AI. The United States federal government should lead the way globally with respect to AI. Importantly, the Executive Order provides a comprehensive list of AI-related definitions, some of which already exist in federal statutes or regulations, but perhaps have not previously been applied across the various industries such as healthcare. The Executive Order then provides specific directives and deadlines to various federal agencies to implement the eight principles. With respect to the healthcare sector, the Executive Order directs the Secretary of the Department of Health and Human Services (“HHS”) to take the following actions: Within 90 days, establish an HHS AI Task Force. Within 365 days of being created, the HHS AI Task Force will develop a strategic plan that includes policies and frameworks and possible regulatory actions on responsible deployment and use of AI and AI-enabled technologies in the following areas: Healthcare delivery and financing, and specifically, quality measurements, performance improvement, program integrity, benefits administration and patient experience Safety and performance monitoring of AI-enabled technologies, including clinically relevant or significant modifications and performance across population groups Incorporation of equity principles for AI-enabled technology using disaggregated data and helping to identify and mitigate discrimination and bias in current systems Safety, privacy and security standards for protecting personally identifiable information Development, maintenance and availability of documentation to help users determine safe and appropriate uses of AI in local settings Determine work to be done with state, local, Tribal and territorial health and human service agencies to advance positive uses cases and best practices Identify uses of AI to promote workplace efficiency, including reduction of administrative burdens Within 180 days, develop a strategy with relevant agencies to determine whether AI-enabled technologies maintain appropriate levels of quality, including the development of an “AI assurance policy” that will evaluate important aspects of performance. This includes an infrastructure to enable pre-market assessment and post-market oversight. Within 180 days, consider appropriate actions needed to advance understanding and compliance with federal non-discrimination laws by healthcare providers that receive federal financial assistance and how those laws relate to AI. Within 365 days, in consultation with other federal agencies, establish an AI safety program in partnership with voluntary, federally listed Patient Safety Organizations. This directive calls for establishing a common framework for identifying and capturing clinical error resulting from AI and developing best practices or other guidelines to avoid harms. Within 365 days, develop a strategy for regulating use of AI or AI-enabled tools in drug-development processes. Given this more specific framework and the guidance and regulations expected to result from this Executive Order, it is also likely that states and Congress will continue to review and develop legislation around the use of AI generally, and in healthcare in particular. This will likely result in a varying assortment of regulations that providers, AI developers and others in the healthcare sector will need to understand and address. AI is here to stay, and healthcare providers will need to be alert to forthcoming laws, regulations and guidance from varying levels of government, as well as from professional organizations. See https://www.ama-assn.org/press-center/press-releases/ama-develop-recommendations-augmented-intelligence (providing that the American Medical Association will be developing principles and recommendations on the benefits and unforeseen consequences of relying upon AI-generated medical advice or content). If you have any questions regarding the current AI regulatory framework or how your organization may be impacted, please contact the author or your Dorsey healthcare attorney.
November 28, 2023
U.S. Supreme Court Expands Options for Residents & Families Suing Nursing Homes
In a ruling issued today, the United States Supreme Court held that the family of a nursing home resident could bring a claim against the nursing home under the Federal Nursing Home Reform Act via section 1983. In Health & Hospital Corporation of Marion County v. Talevski, Talevski’s family claimed that the nursing home where Talevski resided violated his right to be free from unnecessary physical or chemical restraints and his right to only be discharged or transferred upon the satisfaction of certain conditions. The family asserted that these rights arose out of the Federal Nursing Home Reform Act (“FNHRA”), which provides the regulatory provisions to which nursing homes are held and surveyed upon by the Centers for Medicare & Medicaid and state survey agencies. In other words, these regulatory violations can now serve as a basis for a private right of action. As noted above, the case expressly focused on two regulations: the requirement that nursing homes must protect and promote a resident’s right to be free from physical or chemical restraints imposed for purposes of discipline or convenience and not required for the treatment of medical conditions; and the requirement that nursing homes cannot discharge a resident without meeting certain conditions (i.e.., the involuntary discharge requirements). The Court’s majority opinion noted that both of these regulations are within the “resident’s rights” statutory provisions of FNHRA, which has an ‘individual ‘rights-creating’ focus.” The Court also made clear that it is Medicaid-participant nursing homes who are required to respect and honor these rights and thus, who may be sued under FNHRA. In other words, these private rights of action under FNHRA would apply to any facility subject to the regulations in the FNHRA. While the Court recognized that there is already a scheme in place to address the FNHRA violations (i.e., the survey process), it held that allowing a private right of action did not thwart the operation of that administrative process in any way. While nursing home residents and their families always had the ability to sue nursing homes for negligence or malpractice, this decision holds that nursing homes can now also be sued – under section 1983 – by private parties for violating the FNHRA regulations. The impact on nursing facilities is primarily two fold. First, it provides a federal cause of action that would allow a plaintiff to sue a nursing facility in federal – rather than state – court. Second, it provides the plaintiffs in these cases another potential area of financial recovery, because successful claims under section 1983 give the court the ability to award attorney fees. While the full impact of this decision remains to be seen, a few likely impacts should be noted. Plaintiffs’ attorneys will be looking more closely at a facility’s regulatory violations and determining whether they can serve as an additional basis for what would have traditionally been a simple negligence claim. From a practical perspective, nursing homes should take this into consideration when they decide whether they want to challenge a regulatory violation. The potential litigation exposure has increased and thus, it may make sense to spend time and effort challenging a regulatory violation where in the past the nursing home may have just agreed to pay the fine. As noted above, now that a federal private right of action exists, plaintiffs will have more ready access to the federal courts. This will mean new judges and juries that have not traditionally addressed nursing home cases. Additionally, the 1983 action not only gives plaintiffs’ attorneys the ability to potentially recover attorney fees, but the existence of a separate federal claim likely also allows a plaintiff to escape caps on damages that some state legislatures have enacted. In short, the Talevski decision increases the overall financial exposure of nursing facilities.
June 8, 2023
coronavirus
Coronavirus Lawsuits More Than Double In 2021; Those Against Healthcare Providers Steadily Increase
Despite widespread vaccine availability and the corresponding optimism about returning to “normal,” the coronavirus pandemic continues to spawn hundreds of employment and health-related lawsuits. Many of these lawsuits have been aimed at employers in the healthcare sector and relate to workplace safety, retaliation, and wrongful termination or wrongful denial of leave. In fact, since our last update on this topic (available here), the healthcare sector has increased its relative share of coronavirus lawsuits compared to other industries. In December 2020, approximately 20 percent of lawsuits alleging labor and employment violations related to coronavirus arose from the healthcare industry; today, that number is approximately 25 percent. The total number of coronavirus lawsuits has also increased dramatically. At the end of 2020, 1,235 total lawsuits had been filed against employers related to the coronavirus. Today, that number has more than doubled; there have been 2,560 lawsuits, including 200 class actions. States with the most filings include California (666), New Jersey (293), Florida (198), New York (184) and Ohio (156). Whether brought in California, Iowa, or elsewhere, coronavirus lawsuits most commonly assert that employers violated federal and state mandates, guidelines, and regulations regarding employee safety. One such federal mandate was the Families First Coronavirus Response Act (FFCRA), passed by Congress in March 2020 (and, with certain exceptions, expired in December 2020). While operative, the FFCRA required employers with fewer than 500 workers to provide employees with a certain amount of compensated time off for various reasons linked to COVID-19, including if employees become ill. Importantly, however, the FFCRA provided that certain employees—i.e., “health care providers and emergency responders”—may be excluded from entitlement to both emergency family leave and emergency paid sick leave. In addition to FFCRA cases, employees have also filed lawsuits alleging that their employers violated the federal WARN Act (or similar state laws), which in certain circumstances requires that employers with 100 or more employees provide at least 60 days’ notice before conducting a mass layoff. Even though there are fewer lawsuits involving COVID-19 related issues in states like Iowa, the recently filed Iowa cases are representative of the types of cases occurring across the country. In one case, an employee of a hospital asserts that she was terminated after she raised concerns about the lack of available personal protective equipment and about staff failing to wear masks correctly. She also claims that she raised concerns about an social event where staff were attending without masks and without adhering to social distancing guidelines. Another case involves claims by a food manufacturer’s nurse supervisor asserting her employer’s lack of preparedness for COVID-19 and her resulting firing after she raised safety concerns. Although other employment-related cases in Iowa have been filed against employers outside the health care industry, similar cases could be filed against those in the health care industry in the future. These cases include allegations that employers denied leaves of absence for an individual with high risk conditions and failure to implement proper screening, social distancing and other protective measures, which in one case resulted in deaths from COVID-19. On the flip side, Iowa has also seen recent litigation filed with an individual asserting a civil rights violation for requiring students to wear a mask to school. A recent development that may impact future coronavirus litigation is the updated federal guidance on mask mandates. On May 13, 2021, the U.S. Centers for Disease Control and Prevention (“CDC”) revised its guidance to reflect that “fully vaccinated” individuals no longer need to wear masks, whether indoors or outdoors, except in limited circumstances. And while there is a caveat for “local business and workplace guidance,” OSHA is advising employers to follow CDC guidelines for fully-vaccinated employees. Accordingly, employers across the nation now face the practical challenge of maintaining a safe and compliant workplace in an increasingly open environment, while at the same time minimizing their risk for legal liability. While many states have enacted legislation that limits the liability of healthcare providers for actions or omissions during the pandemic, most of the legislation leaves openings for plaintiff’s lawyers to argue that their clients’ claims are not prohibited, especially with respect to employment-related claims. For example, Iowa enacted the “COVID-19 Response and Back-to-Business Limited Liability Act”. Under the Iowa Act, providers cannot be held civilly liable for various actions, which include, but are not limited to screening, assessing, diagnosing, caring for or treating individuals with COVID-19. The Act also provides protection for acts or omissions relating to non-COVID-19 patients, if those acts or omissions result from supporting the state’s response to COVID-19. This may include acts such as providing treatment outside the premises of a health care facility or using equipment and supplies outside their normal use. As seen by the lawsuits described above, the Iowa Act does not prevent the filing of employment-related claims and notably, liability can still be established even in non-employment related contexts if the provider acted recklessly or engaged in willful misconduct. Navigating the highly dynamic landscape of federal, state, and local coronavirus rules and policies presents numerous challenges for employers. But healthcare providers can still employ a number of proactive steps to reduce their potential exposure. Providers should understand their obligations under relevant federal and state law and provide employees protected leave as appropriate. When in doubt, we recommend that employers err on the side of granting the requested leave. Providers should revise company policies as necessary to incorporate the new regulations that apply to COVID-19 exposure and sick leave. To the extent feasible, providers should consider offering teleworking opportunities for eligible employees. Providers should implement a system for recording employees’ requests for leave and the reasons supporting those requests, i.e., an employee’s symptoms and the date for a test or doctor’s appointment. However, providers should not require employees to provide further documentation, such as certification that the employee sought a diagnosis or treatment from a healthcare provider. Providers should be mindful of the risks of taking personnel actions that could lead to discrimination or retaliation lawsuits by workers who requested or took applicable leave. As always, providers should properly document their termination decisions. Providers should carefully consider whether and how they will ask employees to provide proof of vaccination, and they must be aware of relevant legal considerations if making those inquires. Several jurisdictions have implemented laws banning employers from requiring so-called “vaccine passports” or other methods of requiring individuals to provide proof of vaccination to gain access, entry, or service. Providers may initially want to strongly encourage employees to get vaccinated—with the caveat that it may be mandatory in the future—and only require vaccination in the future if absolutely necessary.
June 7, 2021
Long Term Care
Granny Cams Are Likely Here to Stay: Taking Steps to Address the Inevitable
“Granny cams” or family-placed electronic monitoring in a nursing facility have become more commonplace. Cameras are easier to obtain and set up and can easily be linked to one or more family member’s cell phones. With COVID visiting restrictions making it more difficult for families to visit their loved ones in person, more and more people will be considering their options for keeping an eye on their family member living in a long term care facility. Some states have passed legislation to establish certain regulations or parameters around the use of granny cams in the long term care setting. Others, including Iowa, are considering such legislation. Most states, however, do not have any statutory or regulatory requirements and thus, long term care facilities must determine how to deal with use of such cameras. The first question a long term care facility must ask is whether it is advisable to have a written policy. If you are in a state with a statute or regulation on granny cams, you likely should have – and may be required to have – a written policy to comply with those requirements. If you are in a state without any statutory or regulatory provisions on electronic monitoring in long term care, your initial reaction may be that having a policy provided to residents and family members will only encourage them to obtain cameras. However, a resident or family member who wants a camera will likely place one anyway, and you may be better off to at least have a set of ground rules for everyone to follow with respect to such cameras. There are numerous considerations for handling the use of family-placed electronic monitoring in your facility: Is the resident competent to decide if he or she wants a camera in the room? If not, who can make the decision for the resident as to whether a camera can be placed in the room? Financial and medical power of attorneys do not expressly cover the ability to consent to being videotaped, but such consent arguably falls under some of the broad powers generally given to a medical power of attorney. The decision-maker question gets messier if there is no designated medical power of attorney or if there are joint medical power of attorneys who do not agree. Does the resident have a roommate? If so, the roommate has privacy rights that must be considered and protected. A policy can provide restrictions on the direction the camera is pointing and also require that a roommate must give consent. The policy can also address the resident’s options when a roommate does not consent to having the camera in the shared room. Should you require that the family disclose the existence of the camera to you? Any policy should require such disclosure so that proper signage could be placed on the doors to the room alerting people that they may be videotaped while in the room. This disclosure and signage will help reduce or eliminate liability to you (and the family) for possible illegal, covert recordings that may violate state or federal wiretapping and/or communication interception laws. Will the recording be video only or will it include audio? The inclusion of audio increases the complications and issues involved, because it may “pick up” discussions that are confidential or private in nature regarding the resident’s roommate or other discussions that may occur in the hallway or near the room. This issue should be assessed in light of federal and state-specific laws regarding the recording of verbal conversations. Who is responsible for the camera set up and operation and the resulting video? A policy should clarify that the family is responsible for the camera, its operation and the videos that are created by it. If the facility were to take possession of the recordings, it unleashes a whole host of regulatory issues including HIPAA protections and possible self-reporting or disclosure requirements. The policy should place certain restrictions upon the camera, such as requiring a proper electrical connection (i.e., not using an extension cord or draping a cord across a room), where and how it can be mounted or placed and/or generally requiring that the camera be placed in a safe manner that will not cause safety or fire hazards. A facility may also consider whether the use of its private Wi-Fi (and any associated cost) versus public Wi-Fi would be allowed for cameras requiring an internet connection. The policy should also address what happens when the camera malfunctions. For example, if it goes off (like a fire alarm) due to low battery or other complications, can it simply be turned off? Does the family need to be notified when such issues occur? The best bet is to have the facility take little to no responsibility for the actual operation of the camera or its resulting video and rather simply provide parameters around its placement and safe use. What are the evidentiary rules and issues with the camera footage? While this question is not likely something that you can fully address or avoid with a policy, you should consider the possible uses of the video and inform your staff to be aware of these possibilities. Videos could be submitted to the state survey agency and used to confirm or dispute that certain cares were provided, they could be used in criminal actions, and they could be used in civil actions for malpractice. While every state’s evidentiary rules and case law may differ and the facts of how the video was captured and maintained will impact its admissibility, everyone should be aware that their actions may be recorded. Hopefully, this awareness will encourage everyone to do better and at the end of the day, improve the cares that are provided to your residents. If you are operating an assisted living facility, the considerations are slightly different in that the space in which the camera is situated is usually considered more like a personal home and is typically subject to landlord tenant laws. However, some of the same considerations – especially those involving whether the camera is capturing video and audio, ensuring that use of the camera is compliant with federal and state wiretapping and communication interception laws and avoiding fire and other safety hazards with the camera – will need to be addressed. While these are difficult issues that can vary from state to state, facilities should not avoid this discussion. Granny cameras will likely only increase in use, especially as technology improves and as families tend to live further away from their parents or grandparents who are now living in your facility. A clear policy and transparent communications with families on this issue can actually result in a positive relationship. Families will realize that a facility who is willing to allow them to place a camera must feel confident about the good care that will be provided to their loved ones, and everyone will understand the “rules of the game” when using such cameras.
February 25, 2021
Centers for Medicare and Medicaid Services
Nursing Facilities and CMPs: The Latest Fight
On January 18, 2021, a lawsuit was filed against the U.S. Department of Health and Human Services (“HHS”) and the Centers for Medicare and Medicaid Services (“CMS”) challenging a CMS policy change dating back to 2017. The plaintiffs, the National Consumer Voice for Quality Long-Term Care and the California Advocates for Nursing Home Reform, are non-profit consumer advocacy groups for long-term care. The policy at the heart of the lawsuit concerns a change CMS made as to how civil monetary penalties (“CMP”) are imposed against nursing facilities. As a bit of background, under the Nursing Home Reform Act of 1987 (NHRA), Congress created a scheme whereby CMS and the states shared responsibility for ensuring states meet federal quality and safety standards of resident care for residents in nursing facilities. Under this scheme, state agencies regularly evaluate a nursing facility’s compliance with the requirements by conducting periodic surveys, often unannounced. The survey findings would then be reported to the CMS regional offices (“RO”) with recommended enforcement actions. Acting on the survey results and the recommendation from the state agency, the ROs would then impose per-day CMPs on facilities for past noncompliance with federal standards. The 2017 change, however, made clear that ROs, regardless of findings and recommendations from state survey agencies, are to impose a CMP for past noncompliance based only on each instance of noncompliance that occurred but was corrected before the state survey is conducted. “Past noncompliance” is a statutorily defined term which means those situations in which a state finds that a nursing facility meets all of the federal requirements “but, as of a previous period, did not meet such requirements.” With this 2017 policy change, if a facility has corrected that noncompliance just before the survey team shows up at the facility, even if the noncompliance had lasted months, then the facility would not be penalized for each day of noncompliance but rather, would receive a “per instance” CMP. The plaintiffs in the recently filed litigation argue that, by announcing to the state survey agencies that its ROs will assess CMPs only for each instance of past noncompliance and not for each day of past noncompliance, CMS’ policy change effectively contravenes Congress’ express intent to give the states the direction to recommend (and CMS the discretion to impose) a per-day CMP for past noncompliance. The complaint alleges that the plaintiffs have been adversely impacted by this change. Per instance CMPs currently range in amount, as adjusted for inflation, from a minimum of $2,233 to a maximum of $22,320 for each instance of noncompliance. 42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3. Taking the example of a non-immediate jeopardy deficiency, the maximum per-instance CMP that a nursing facility faces for this type of deficiency is $22,320, regardless of whether the facility has allowed the deficiency to remain uncorrected for one day, one week, or one month. By contrast, the maximum per day CMP for this type of deficiency begins to exceed, and quickly dwarfs, the maximum per instance CMP whenever the facility has allowed the deficiency to remain uncorrected for four or more days (4 x $6,695 = $26,780). The plaintiffs argue that the imposition of only per instance CMPs for past noncompliance will thus encourage nursing facilities to knowingly allow deficiencies to linger for days, weeks, or even months, until the next state survey, because the penalty will be the same regardless of whether the deficiency persisted for a day or a month. As long the facility remedies the deficiency before the next survey (usually 12-15 months apart), the facility can only be fined the per instance maximum of $22,320. The human impact of this, as argued in the lawsuit, is that for each day a facility permits a deficiency to persist, whether it be for one week or a number of months, the residents at that facility may be endangered by the deficiency. As a result, the plaintiffs assert that if facilities do not fear the monetary penalties, they will be less inclined to make their facilities safe for residents. Certainly, nursing facilities across the country will see it very differently from the plaintiffs in the litigation. Because surveys are unannounced, facilities do not “let down their guard” and intentionally allow the facilities to become less safe simply because they know they will be assessed a per instance penalty instead of a per day penalty. Rather, the possibility of getting a per instance CMP (as opposed to a per day penalty) would be an incentive for nursing facilities to identify and correct issues immediately so that such issues will be identified as past noncompliance when the state survey agency does come knocking. While there may be some bad actors out there, most nursing facilities are doing all that they can to avoid noncompliance. In other words, facilities’ actions and decisions are not based upon whether they would rather have a per day versus a per instance penalty. It is also notable that, while the litigation mentions the COVID-19 pandemic, it does not mention the enhanced CMPs that are now available for infection control violations. CMS has been aggressively using these enhanced CMPs to impose large per instance and large per day CMPs for relatively low-level transgressions. For example, having one employee make an error on his/her mask wearing or daily documentation regarding COVID-19 symptoms (even if it does not lead to any adverse consequences) can result in a $15,000 CMP if the facility had any infection control deficiency in the last two years. A surveyor may see a staff member not following the requirements every time (e.g. not wiping down the face shield after they sit it down for a few seconds, letting their mask fall below their nose, etc.) and may assess severe penalties as a result. While most facilities would agree that infection control is important, these penalties are excessive, especially taking into account they are assessed for some of the more minor and isolated events that may occur. Facilities should be cognizant of this litigation and the views expressed by the organizations seeking to change the CMP landscape to be harsher than it is now. CMS has already shown its willingness to increase the CMP levels for infection control purposes, and they may seek to expand such penalties on a more permanent basis. If you have any questions about any of the topics addressed in this post, please contact the authors or any member of the Dorsey & Whitney Health Transactions & Regulations Practice Group.
February 10, 2021

