Healthcare Law: Navigating Our Complex System

Josh Abrams, adjunct professor at Northeastern University’s School of Law, outlines the fundamentals of healthcare law in the U.S.

When one hears the term “healthcare law,” many people think of medical malpractice. As a healthcare attorney, this can be frustrating, because it’s a tiny slice of a much richer and broader pie, and representative of a moment in the patient-provider relationship when things have already broken down.

Sadly, it’s this area of healthcare law that most people are exposed to—the intersection of a perceived failure of clinical care within a legal framework designed to respond to that perceived failure. Healthcare law, however, is much more broad, complex, and proactive than this narrow corner of the field. So if it’s not just medical malpractice law, then what is it?

What Is Healthcare Law?

Healthcare is a highly regulated field, and all of those regulations require legal frameworks to make sense of them. For example, the field of licensing and healthcare oversight is a body of law designed to ensure that healthcare is only provided by people who are appropriately trained and educated to provide such care. Much of this is state-law based, relying on the statutory definition in each state that sets out what is the “practice of medicine,” the “practice of nursing,” or the practice of other licensed healthcare providers.

Who Is Responsible for Regulating the Healthcare Industry?

Boards of medicine, nursing, and other practices are tasked with ensuring that providers in their disciplines don’t stray outside those statutory definitions, and that non-licensed professionals don’t overstep their bounds. Professionals with legal training are needed to both represent individual clinicians, as well as to represent the boards in their important roles protecting the integrity and quality of healthcare provided in their jurisdiction.

Other regulatory bodies, on both the federal and state levels, are tasked with overseeing different aspects of healthcare, including the pharmaceutical industry and medical device companies. The Food and Drug Administration oversees the testing and approval of new medications, the Drug Enforcement Agency regulates the prescribing practices of such substances, and various state and federal agencies ensure that hospital beds, wheelchairs, needles, and other medical equipment are safe and effective. Complying with, or challenging, these regulations requires guidance from those with legal training.

Critical Healthcare Regulations

There are many healthcare law practices that focus directly on legal issues impacting the provision of direct patient care—which, in many ways, can be boiled down to issues of consent and confidentiality, or, “What can a provider do, and who can he or she tell?” The Health Insurance Portability and Accountability Act (HIPAA) sets out a complex, but critically important, statutory framework for protecting the confidentiality of patients’ medical information on the federal level. States build on that regulatory floor to provide greater protections for certain categories of medical information, such as mental health, HIV, and genetic information. Other federal regulations provide very high levels of confidentiality for substance use disorder treatment records.

All of these laws run directly in tension with the concept of coordinated care, where medical information flows freely to allow for maximum quality of care. Understanding how these confidentiality laws and the clinical imperative to share patient records to provide safe and effective care can coexist—and how to manage the tensions that are created by these opposing legal and clinical forces—requires subtle understandings of statutory and regulatory language as well as the enforcement mechanisms that underly them.

Finally, there are statutes and regulations that define consent, as well as who can provide consent when the patient is unable to do so. Providers need legal guidance to determine what they can do when a patient or their surrogate is refusing or demanding care that run contrary to the recommendations of the care team. And then there is legal tension that can be created when bioethical standards or provider values conflict with the patient or surrogate’s wishes. Al of these issues, which are examples of the how clinical care and the law are constantly intertwined, provide opportunities for those with legal training to guide parties on all sides of these matters.

Beyond Clinicians: The Impact of Healthcare Law

There are many other federal and state laws that require health law-related legal expertise to understand. The Employee Retirement Income and Security Act of 1974 (ERISA) and the Patient Protection and Affordable Care Act (also known as Obamacare), for example, regulate health insurance and employee benefit plans to ensure that health insurance and other benefits are provided in a meaningful way that protects the rights of beneficiaries.

Whether you’re a lawyer, paralegal, clinician, hospital administrator, patient advocate, or guardian, having legal training in health law gives you an opportunity to represent the interests of your clients in this complex and ever-evolving healthcare law environment. There are endless ways to use a legal education in this field, and a growing demand for people with such knowledge in the workplace. A Master of Legal Studies program, with a concentration in healthcare law, gives you access to much of this training, and an opportunity to increase your value to your employer and its attorneys.

An educated employee can help cut legal costs and resources by allowing more straightforward legal issues to be resolved before involving legal counsel, keeping lawyers focused on the most complex legal issues facing the organization. Learning about and mastering healthcare law will give you the tools to understand how this complex legal framework fits together, and provide you with an opportunity to grow your career as a critical resource to your employer.