Category:Healthcare Compliance
From Chatbots to Diagnosis: The Power and Pitfalls of AI in Healthcare
The capabilities of generative artificial intelligence (AI) could completely transform our healthcare system as we know it. For better or for worse, the technology advancements in healthcare are rapidly growing. Given the accelerated rollout, experts have yet to predict all the risks associated with such high-functioning computations in the healthcare system. Even though the Food and Drug Administration (FDA) regulates software being used as medical devices (SaMD), there is an overall lack of urgency, agency oversight, and sufficient regulations to tame AI technology in the healthcare system.
Exploring the Ramifications of the Department of Justice’s Withdrawal from Health Care Antitrust Guidelines
On February 3, 2023, the Department of Justice (DOJ) formally withdrew its support for three policies that created longstanding safe harbors from antitrust enforcement, relied upon by the healthcare industry for nearly thirty years. Assistant Attorney General, Jonathan Kanter, of the DOJ’s Antitrust Division stated that these changes were “long overdue”, and that the, “[DOJ] will continue to work to ensure that its enforcement efforts reflect modern market realities.” In striking these guidelines, the DOJ notably left no new guidelines in its place, leaving many healthcare providers and purchasers uncertain of whether they will face litigation or even criminal prosecution under the Sherman Act.
The Future of Telemedicine: Controlled Substance Proposed Rule
On January 31, 2020, the Secretary of the Department of Health and Human Services issued a public health emergency as a result of COVID-19. The emergency declaration requires public health professionals, first responders, and public officials to work together to minimize death while preventing illnesses. The declarations provided the government with the flexibility to waive or modify standard requirements as it relates to both public and private insurance, service providers, and authorizations including telehealth. Telehealth provided access to healthcare to those who face barriers as well as flexibility in being able to manage care while reducing the spread of COVID-19 along with other infectious diseases. There remained uncertainty regarding the freedom to prescribe controlled substances via telemedicine with the Biden administration set to end the public health emergency on May 11, 2023. However, on February 24, 2023, the Drug Enforcement Administration (DEA) released a proposed rule that aims to permanently extend controlled substance prescribing flexibilities.
AI-ming for Better Healthcare: Legal Issues in Healthcare AI Usage
Artificial intelligence (AI) is a simulation of human intelligence that is subsequently processed by machines. It has revolutionized the healthcare space by improving patient outcomes in a variety of ways. It has also begun to leave a positive impact in health systems and hospitals as healthcare worker burnout remains on the rise. However, there are significant legal challenges that accompany its groundbreaking nature. Hospitals and health systems have a duty to mitigate these legal challenges and understand that AI should be used as a supplement, not a replacement, to human intelligence.
The FTC’s Enforcement Action: GoodRx’s Failure to Protect Its Customers’ Personal Health Information
On February 1, 2023, the Federal Trade Commission (FTC) brought an enforcement action against GoodRx, a provider of telehealth and prescription drug services at discounted rates. In a first-of-its-kind action, the FTC alleged that GoodRx violated the Health Breach Notification Rule (HBNR) by sharing their consumers’ confidential health information with several advertising companies. While GoodRx is already facing a $1.5 million penalty for the violation, the FTC has also proposed an order that will require GoodRx to remedy the situation and make several changes to protect confidential health information in the future.
How the FTC’s Proposed Non-Compete Rule May Impact Non-Profit Hospitals
On January 18, 2023, the Federal Trade Commission (FTC) proposed a new rule for regulating non-compete clauses. The proposed rule, which has been named the “Non-Compete Rule,” could potentially ban employers from entering into, or attempting to enter into, a non-compete clause with employees and independent contractors collectively referred to as “workers.” The proposed rule has recently sparked several discussions on the scope and constitutionality of the rule. One concern is how the proposed rule, if finalized, would impact the healthcare industry and especially non-profit hospitals.
Improving Safety and Quality of Care in Poor-Performing Nursing Homes
The Centers for Medicare and Medicaid Services (CMS) manages an oversight program for nursing homes known as the Special Focus Facilities (SFF) program. Nursing homes that are placed in the program have almost double the deficiencies as other nursing homes, more serious issues in terms of injury and persistent problems that are never addressed. On October 21, 2022, CMS issued a press release regarding changes to its SFF program. The new changes will increase accountability for these facilities and encourage them to make quicker improvements. This action comes following the Biden-Harris Administration’s promise to increase safety and quality of care in poor-performing nursing homes.
DEA Attempts to Regulate Telehealth Prescription of ADHD Medication
The U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA) have guarded controlled substances zealously since the inception of the Controlled Substances Act (CSA), passed in the 1970s. However, the coronavirus (COVID-19) pandemic challenged nearly all of society’s conventional protocols, and the federal government responded to concerns that patients wouldn’t receive care by loosening its regulations for healthcare services. In 2020, the DEA permitted health providers to prescribe schedule II-controlled substances to patients via telehealth appointments instead of in-person visits. Now, two years later, the FDA has confirmed an Adderall shortage, which is a schedule II controlled substance that is in high demand and used to treat attention-deficit/hyperactivity disorder (ADHD). The Justice Department’s DEA division has initiated probes against various online mental health companies and worries that the drug is overprescribed and abused by young adults.
Post-Pandemic Telehealth and the Fate of Adderall
During the COVID-19 pandemic, the federal government and the Drug Enforcement Agency (DEA) temporarily lifted the Ryan Haight Act’s mandate that imposes federal prohibition on online prescribing of controlled substances. The DEA waived its in-person medical examination requirement and set forth different criteria for controlled substances. For as long as the duration of the public health emergency (which was extended through January of 2023 this month), a patient can receive a controlled substance prescription without an in-person examination if the communication was conducted in a two-way, audio-visual, and real-time interactive communication. Covid highlighted the increased use of telehealth and digital health platforms. However, as telehealth surged, public policy has failed to move at the same speed.
Home Health Care: Cost-Effective, Convenient, and Vulnerable to Fraud
Home health agencies (HHAs) provide health care services to assist individuals with a disability, or who are ill, injured, or elderly. It is a cost-effective and convenient method of receiving quality care that is provided from the comfort of the patient’s own home. While HHAs have been around for years, primarily to serve the elderly and avoid hospitalization, the post-pandemic “at-home” era has made it the fastest-growing healthcare industry in the country. However, the high demands and good intentions of instilling home health agencies come with its adverse counterpart- fraud and abuse.