Legal and Compliance Issues in Healthcare: How an M.L.S. Helps

Compliance requirements address the hazards that exist within the healthcare space, touching on everything from patient safety to data privacy, equity, and public health.

By Miami Law Blog Contributor 06-05-2025

The modern healthcare sector bears major responsibilities: keeping patients, their loved ones, and their personal data safe while also navigating ethical complications and an ever-expanding series of regulatory requirements.

Offering a roadmap to address these challenges is healthcare compliance. This keeps providers accountable, ensuring that they follow the numerous rules and regulations designed to safeguard patients.

These regulations, although necessary, are notoriously complex — and in the push for innovation and efficiency, healthcare providers risk non-compliance. This carries not only penalties (such as fines or exclusion from programs such as Medicare) but also grave risks for patients and even clinical professionals. After all, healthcare rules and regulations are created with their best interests in mind.

To maximize protection and avoid healthcare legal issues while adhering to strict healthcare requirements, today's providers implement robust compliance programs that incorporate advanced software and draw on the expertise of highly trained professionals. These compliance teams may seek diverse perspectives, but valued insights in this niche can come from Master of Legal Studies (M.L.S.) graduates. Keep reading to learn why the M.L.S. matters and how it influences healthcare compliance.

Healthcare Compliance and the Legal Landscape

Compliance forms the critical foundation underscoring attentive and effective patient care. It provides the structure and guidance that healthcare organizations and their hardworking clinical teams need to uphold ethical standards and maintain a high quality of care.

The Role of Laws and Regulations in Healthcare

The healthcare system has an outsized impact on our economy, our communities, and our future. This determines everything from longevity to emergency response, influencing our day-to-day comfort and our overall quality of life. It is also a key driver of innovation, plus a major source of public and private spending.

Given this incredible influence — and the dire implications that could accompany a poorly functioning healthcare system — it is reasonable to assume that healthcare organizations, programs, and professionals will be asked to abide by a strict set of rules governing everything from infection control to patient privacy and billing practices.

A report published in the Journal of Public Health Management and Practice details the societal value of healthcare laws and policies, referring to these as "critical determinants of health and well-being." These are thought to promote "positive behaviors and discourage harmful behaviors," all while holding the power to "enhance or worsen health, health equity, health disparities, and health literacy."

Key Healthcare Compliance Laws in the United States

Healthcare rules and regulations have shifted considerably over time, reflecting not only key developments in the healthcare industry but also society's evolving stance on the role of healthcare, which is increasingly viewed as a human right.

For more than a century, healthcare regulations were largely handled at the state or local level, with minimal federal intervention. That began to change alongside developments such as the National Quarantine Act of 1878, which gave the federal government the impetus to limit the introduction of infectious diseases. Later, the establishment of Medicare and Medicaid expanded the government's role in promoting access to healthcare services, while the Emergency Medical Treatment and Labor Act (EMTALA) mandated that hospitals provide emergency care, even if patients were unable to pay.

As digital solutions began to play a greater role in the healthcare sector, the need for relevant legislation became abundantly clear, leading to the Health Insurance Portability and Accountability Act (HIPAA). Enacted in 1996, this aimed to safeguard patients' private health information and led to the implementation of strict security protocols and confidentiality requirements.

Today, compliance efforts in healthcare are largely center on HIPAA and another influential healthcare law: the Affordable Care Act (ACA), focused on expanding coverage and preventing insurance companies from denying patients on the basis of pre-existing conditions.

The Importance of Compliance in Healthcare

Compliance serves numerous important purposes in the healthcare sector, promoting access to care along with high standards to keep patients and healthcare professionals safe. In addition, compliance addresses the financial, technological, and privacy implications of healthcare services, along with the many other ways in which the healthcare sector can influence individuals, families, and entire communities.

Protecting Patient Rights and Privacy

In the resource Patient Rights and Ethics, the authors argue that patient rights form a subset of human rights. These involve "minimum enforceable standards" for how patients can expect to be treated. Examples include the right to non-discrimination, the right to receive clear information about their care, and the right to be treated with dignity. Regulations such as HIPAA recognize that patients also have a right to privacy, imposing limits on who can view protected health information.

Compliance forms a framework for ensuring that these rights are consistently prioritized and upheld. This demonstrates the importance of protecting patient rights, with compliance programs giving providers the tools and knowledge needed to advocate for patients while providing respectful and equitable care.

Ensuring Quality and Safety in Healthcare Services

While professional organizations like the American Nurses Association (ANA) and the American Medical Association (AMA) implement detailed guidelines to clarify scopes of practice and promote high standards of care, additional accountability is needed among providers to ensure that all healthcare services are delivered safely and with patients' best interests in mind. Compliance promotes this while also improving transparency across the vast spectrum of modern healthcare.

Introduction to Master of Legal Studies in Healthcare

A Master of Legal Studies is a career-focused graduate program that aims to equip aspiring non-attorney professionals with an understanding of the law. Covering legal frameworks and principles, these programs set the stage for success in diverse fields and roles, including numerous career paths that emphasize compliance. An M.L.S. often involves targeted tracks or concentrations, such as a healthcare law and regulation track that aspiring compliance officers may find compelling.

Overview of M.L.S. Programs Focused on Healthcare

Healthcare-focused M.L.S. programs introduce aspiring compliance professionals to the wide range of rules, regulations, and frameworks that currently shape the healthcare system — revealing what exactly it takes for healthcare providers to remain compliant and where common compliance challenges may emerge. These programs also emphasize critical thinking and problem-solving in the context of healthcare compliance, providing opportunities to practice putting advanced compliance modalities into action.

How an M.L.S. Prepares Professionals for Compliance Roles

An M.L.S. helps aspiring compliance professionals develop the legal knowledge and actionable skills needed to navigate a variety of compliance challenges in the healthcare sector. These include a broad overview of healthcare regulations, along with in-depth insights into coding guidelines, healthcare information privacy, and even the evolving role of artificial intelligence (AI) in the healthcare sector.

This degree program introduces students to foundational legal concepts, but not in the context of legal practice; rather, the goal is to explore the rules and regulations that shape the modern healthcare landscape while helping future compliance professionals understand how they can help organizations abide by these requirements.

Navigating Healthcare Compliance with an M.L.S. Degree

Many purpose-driven professionals contribute to today's robust healthcare compliance efforts, but the need for legal knowledge is increasingly evident. It takes extensive legal training to fully understand the implications of HIPAA, ACA, and other impactful regulations. An M.L.S. can prepare future compliance leaders to navigate the healthcare sector's complex regulatory environment, all while integrating ethical considerations and reflecting a deep commitment to upholding patient rights.

The Intersection of Law, Ethics, and Healthcare

The interplay between law, ethics, and healthcare can seem complex, but all three play a critical role in shaping patient care, data privacy, and revenue cycles. Ethics form the foundation, with principles such as beneficence (doing good), nonmaleficence (avoiding harm), autonomy (self-determination), and justice (fair treatment) — ideally shaping patient care.

These ethical standards guide the development of healthcare laws, which, in turn, promote accountability and transparency. Without these laws, adherence to ethical standards may prove uneven, subject to varying interpretations or priorities. Compliance forms the bridge linking these three areas and driving the actions that ultimately contribute to higher standards of care.

Real-World Applications of an M.L.S. in Healthcare Compliance

M.L.S. graduates can have a considerable impact on compliance in healthcare, playing a central role in developing and implementing compliance programs while also advocating for compliance on an organizational level. Often, their work involves in-depth legal interpretations, especially when other compliance professionals lack legal expertise.

For example, M.L.S. graduates focused on Medicare or Medicaid billing may analyze the Centers for Medicare & Medicaid Services (CMS) requirements to shape billing guidelines or auditing procedures. Additionally, M.L.S. graduates could guide compliance efforts as they relate to clinical trials and institutional review boards (IRBs).

Compliance Challenges in Healthcare Today

As healthcare technology continues to advance — and especially as artificial intelligence assumes a greater role in this field — compliance challenges can be expected to evolve, too, with new rules and regulations addressing the ethical implications of emerging technologies namely as they relate to patient privacy.

Adapting to Changing Healthcare Laws and Regulations

The healthcare landscape has shifted substantially in the last several years. While compliance efforts should continue to emphasize adherence to requirements from HIPAA, ACA, and other healthcare regulations, developments that may be on the horizon should be top of mind as well. This means keeping a close eye on regulatory activity, including proposed laws at both the state and federal levels.

As new regulations are enacted, organizations may need to adjust policies and protocols, making necessary operational changes or updating employee training initiatives to reflect these changes while maintaining a consistent culture of compliance.

The Impact of Technology on Healthcare Compliance

Although technology forms the basis for many of today's most noteworthy compliance challenges, it also can be a key part of the solution. Several well-designed solutions promise to streamline monitoring and reporting. For example, automated risk assessments can identify gaps in security, with continuous control monitoring offering real-time insights regarding critical safeguards.

In the event of an audit, evidence collection tools offer proof of compliance — gathering system logs, access control lists, and encryption certificates that demonstrate how organizations have worked proactively to maintain compliance with stringent regulations.

Implementing Effective Compliance Strategies

Healthcare organizations that prioritize compliance demonstrate an ongoing commitment to implementing policies that improve adherence to critical rules and regulations while also promoting compliance from the ground up. Ideally, these compliance solutions will align with overarching strategic efforts, including core values and objectives.

Developing a Culture of Compliance within Healthcare Organizations

Compliance does not simply represent a top-down effort. Policies and enforcement do matter, but employees need to be fully invested to consistently abide by these requirements. They should understand why compliance matters and how it relates to their personal goals or providing high-level care on behalf of their patients. This begins with creating a culture of compliance, in which regulatory standards are well-understood, and all employees feel committed to upholding these requirements.

Compliance Best Practices for Healthcare Providers

The Office of the Inspector General's (OIG) General Compliance Program Guidance (GCPG) offers an overview of recommended compliance program infrastructure, detailing key elements such as:

Written policies and procedures – Presenting a clear roadmap for compliance programs, codes of conduct and policies should outline specific processes in areas such as coding, billing, and quality of care, all while aiming to foster a culture of compliance.
Leadership and oversight – The OIG recommends strict oversight of compliance programs by compliance officers and compliance committees, which may include leadership from relevant departments such as risk management, IT, and human resources.
Training and education – Compliance-focused training programs should ensure that all employees are aware of regulatory requirements and their role in upholding these. This is crucial from a prevention standpoint; employees are less likely to uphold key policies if they do not understand why they exist or how their conduct contributes to overarching compliance measures.
Lines of communication – Open lines of communication support compliance, making employees more willing to seek clarification regarding critical policies or, when relevant, report possible violations. This may facilitate a swifter response in the event of policy violations, allowing organizations to take corrective actions.
Enforcing standards – In the event that policy violations are revealed, compliance programs should incorporate consequences that are consistently enforced to promote adherence as well as serve as a deterrent.
Risk assessment, auditing, and management – Formal compliance risk assessments provide a structured approach to identifying and analyzing risks, drawing upon insights about risks stemming from numerous internal and external sources.
Corrective action – Despite implementing well-rounded, proactive policies and enforcement mechanisms, healthcare organizations may still be vulnerable to noncompliance. When this is detected, corrective actions should be taken to limit the potential for future healthcare legal issues.

The Role of Compliance Officers in Healthcare

Compliance officers bring structure, guidance, and accountability to the healthcare sector, leaning on their advanced legal knowledge to help organizations understand how they might be impacted by evolving healthcare legal issues. They play a key role in developing policies and procedures relevant to HIPAA and other healthcare regulations.

Key Responsibilities and Skills of a Healthcare Compliance Officer

Compliance officers bring much-needed legal expertise to the healthcare sector — overseeing comprehensive compliance policies and activities to ensure that healthcare organizations consistently abide by a complex series of regulatory requirements. Key responsibilities include:

Developing and implementing relevant compliance plans, policies, and procedures.
Organizing training programs or workshops to keep healthcare employees abreast of compliance requirements or new developments.
Overseeing documentation efforts to ensure that detailed and accurate records demonstrate adherence to regulatory requirements.
Identifying and assessing potential compliance risks, using monitoring solutions and auditing to determine whether compliance programs are effective.

While in-depth legal knowledge can support this effort, compliance officers must also develop management skills that allow them to communicate effectively with a variety of stakeholders, along with an in-depth understanding of technological solutions and data-driven mechanisms that support effective risk identification and analysis. Soft skills such as critical thinking and problem-solving allow compliance officers to develop creative solutions to address complex compliance challenges.

How an M.L.S. Equips Professionals for Compliance Leadership

A Master of Legal Studies helps future compliance leaders develop the knowledge and confidence needed to assertively advocate for policies or protocols that promote compliance in healthcare. Upon graduating from this program, aspiring compliance leaders should feel prepared to take on high-level compliance opportunities that grant them considerable oversight regarding major healthcare compliance programs.

Careers in Healthcare Compliance

Healthcare compliance is more diverse than many might realize. In addition to working as compliance officers, M.L.S. graduates can explore numerous other compliance-related opportunities. Many professionals focus on specific aspects of compliance — addressing, for example, targeted regulatory requirements or various components of compliance programs.

Career Opportunities with an M.L.S. in Healthcare Compliance

While many M.L.S. graduates find rewarding work as compliance officers, there are various ways to leverage legal knowledge and make an impact in the healthcare industry. Opportunities worth exploring include:

Privacy officer – As new privacy laws are enacted, there is an increasing need for specialized compliance professionals who focus on protecting patient data. Known as privacy officers, privacy specialists, or HIPAA compliance officers, these professionals develop policies surrounding the use of protected health information, often working closely with IT to develop and enact HIPAA-compliance security standards.
Regulatory affairs specialist – Relevant to the healthcare sector but often employed in areas such as pharmaceuticals or biotechnology, regulatory affairs specialists are on the front lines of regulatory changes, revealing how these apply within specific industries or niches and offering targeted recommendations to confirm that these meet strict safety requirements.
Risk management specialist – There exists a great deal of overlap between compliance and risk management, with (as mentioned previously) risk assessments and monitoring purposefully built into compliance programs. Risk management specialists may draw from compliance knowledge to identify possible risks that could prevent healthcare organizations from complying with critical regulations.

How an M.L.S. Can Position You for Success in Compliance

An M.L.S. provides a powerful first step toward pursuing a fulfilling career in healthcare compliance. This degree delivers not only the foundational knowledge needed to succeed in this demanding field but also opportunities to network with tomorrow's most influential compliance professionals. Take this opportunity to explore the world of compliance in healthcare and practice navigating the industry's many challenges so that, upon earning your M.L.S., you can be part of the solution.

Explore Healthcare Compliance Opportunities with an M.L.S.

Prepare for an impactful future in healthcare compliance. It all begins with earning your online Master of Legal Studies from the University of Miami School of Law. We offer multiple M.L.S. tracks — but if you are fascinated by the evolving healthcare landscape and determined to protect patients, you might consider an M.L.S. degree with a specialized healthcare administration track. Reach out to request more information today.

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