Legal and Ethical Challenges Within the Health Professions

Legal Responsibilities

As health professionals, members of the professions must comply with a myriad of federal and state laws and regulations as well as regulations protecting clients. If these are followed, then your risk of a civil or criminal lawsuit will be substantially decreased. A few of the most important relevant body of laws and regulations are:

The federal anti-kickback statute, 42 U.S.C. §1320a-7b(b) (2002), makes it a felony to offer remuneration to induce either the referral of any service under Medicare or Medicaid or the purchase or lease of any items or services reimbursable under these programs.
The Civil Monetary Penalties Law ("CMP"), 42 U.S.C. §1320a-7a(a)(7) (2002), authorizes the Secretary of Health and Human Services ("HHS") to impose fines and civil monetary penalties on any person who willfully offers or pays any remuneration to any individual to induce such individual to reduce or limit services provided with respect to items or services covered under Medicaid or Medicare.
The Physician Self-Referral Statute (the "Stark Law"), as amended by the Balanced Budget Act of 1997, 42 U.S.C. §§1395nn(a) (2002) , prohibits a physician from referring patients to a "designated health services" entity (including, in some cases, a laboratory) for certain types of services if the physician has a specified financial relationship with the entity and the service is otherwise payable by Medicare or Medicaid.
The Federal False Claims Act, 31 U.S.C. §3729 (2002) imposes liability on any person who knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval to the United States or to an agent of the United States, including claims that are false because the claims were submitted as a result of undue influence by physicians with respect to medically unnecessary services.
Most states also have professional licensing regulations.
Most employers will require strict adherence to all rules and regulations set forth by federal and state laws and regulations as well as by the employer agency itself.

The "best defense" is to follow the rules and regulations, protect your own interests from those who intentionally or negligently harm you and try to get along with others.

Ethical Concepts

Guiding the conduct of health professions are a similar set of ethical principles. The principles of autonomy, beneficence, non-maleficence, and justice impact clinical decision making and the delivery of care. In providing a service or benefit to a patient or client, as a general expectation, a professional will act without certain limitations of action. A professional will not intentionally harm a patient. Further, a professional should stay within the scope of accepted practice. At times, an action may require a balancing of ethical principles that could alter the analysis of whether the conduct of a professional is unacceptable or harmful to a patient or client. Practitioners in the health professions know it is important to discuss medical needs with patients. Whether a practitioner must provide a greater level of communication depends upon the circumstances of each case. Often it requires knowledge of, and consideration for, the specific wishes of the patient. In situations where a patient communicates a desired medical or surgical outcome, it may be important to provide services to a patient that clearly represents the intention to allow a patient to understand the risks and benefits of such an approach. Clearly, situations often arise when ethical concerns will merit strict adherence to the four principles of autonomy, beneficence, non-maleficence, and justice. Moreover, the legal and regulatory obligations will often seek to protect patient rights based upon such principles. At the same time, the effective management of these cases may require the level of understanding that can only be offered through the experience of proven legal counsel.

Privacy and Confidentiality Issues

The legal and ethical requirements regarding patient confidentiality touch every sector of the health professions. The American Hospital Association summarizes these requirements, explaining, "Patient-physician confidentiality has a rich and long tradition. Legally, the origins of confidentiality in health care date back centuries. This tradition is apparent in many state laws and in the federal law commonly known as the Health Insurance Portability and Accountability Act (HIPAA) [that] establishes national standards to protect individuals’ medical records and other personal health information." HIPAA protects the privacy and security of patient information in traditional contexts such as hospitals and nursing homes. Patient data security is a pressing concern for healthcare organizations even in otherwise legal areas such as pharmaceutical or nutritional supplement marketing. Recent high-profile data breaches illustrate the risk of exposure to major fines and lawsuits under HIPAA and other laws for even relatively minor indiscretions such as emailing sensitive documents. While compliance with HIPAA is just as critical on eHealth platforms and in eHealth apps, the rapidly-evolving legal and technical standards for eHealth present particular risks for health care organizations, eHealth platforms and app developers. Breaches in security and a lack of patient privacy can trigger criminal charges, civil lawsuits and regulatory punishment under laws such as the California Confidentiality of Medical Information Act.
Patient privacy is a touchy subject because of how it is so closely linked to personalized medicine. Privacy protection has moved this technology forward, and constant innovation in mobile eHealth technologies is challenging traditional notions of patient privacy and security. Patients require privacy when tracking their symptoms, taking medication, drinking, eating, exercising, and managing other aspects of their health. With new technologies, such as health trackers that chronicle patient eating, drinking and exercise habits, increasingly ubiquitous, protecting this privacy while still allowing the industry to develop these new technologies is increasingly complex.
There are legal requirements at the state level as well. In California, for example, the California Medical Information Act (CMIA) requires that patient data be kept confidential and allows patients to sue for damages when there is a violation of the act. Patients can sue for up to $1,000, plus damages, for non-egregious violations. Egregious violations can cost up to $50,000 per violation.

Informed Consent: Legal and Ethical Considerations

With regard to informed consent, the physician or health professional is legally obligated to obtain informed consent in three aspects: (1) the patient must be informed of the risks and benefits of the proposed procedure or treatment, (2) the patient must be informed of the risks and benefits of alternative treatments and procedures, and (3) the patient must be informed at the same level of detail about the risks and benefits of foregoing the procedure or treatment. The patient is not obligated to read or engage with the disclosed information.
The threshold question that one must ask when analyzing informed consent issues in the healthcare profession is whether it is necessary to obtain informed consent. The answer to that question is "yes" in most circumstances; however, under some circumstances, such as certain mental health treatment for the duration of the consent period, some emergency situations, and certain intoxicated or mentally incompetent situations, informed consent is not necessary. See generally Fink v. Rhea, 9 Ohio St. 3d 32, 458 N.E.2d 755, and cases cited therein.
Obtaining informed consent is not a mere gathering of signatures on a line; informed consent is a process of communication among the physician or health professional, the patient, and/or the patient’s surrogate to support the patient’s autonomy in the decision-making process between proscribing physician and shared decision making. A common misconception about informed consent is that the law favors the physician; in fact, the law mandates that the physician or health professional create the opportunity for informed patient autonomy through the patient education process.
Patients have the right to receive sufficient information to make intelligent and informed choices regarding their treatment, and the physician has a duty to provide this information. A physician’s ethical obligation to disclose information to a patient not only stems from state laws and patient rights statutes, but also from the lay person’s common law right of self-determination. Doctors have always relied on the ethical principles of informed consent; legislation codifies what has always been commonly required.
As part of the process for obtaining informed consent, physicians must document informed consent in writing. If a patient refuses treatment, that should also be documented. Informed consent documentation requirements have become onerous over the years, and so there is a need to streamline informed consent forms while meeting the legal and ethical needs thereof. Electronic health record systems have addressed this concern and can facilitate informed consent documentation.
Another issue related to informed consent concerns clinical trials. There is a difference between experimental treatment and investigational treatment. Informed consent in the research environment is governed by the Common Rule, codified in the Department of Health and Human Services regulations at 45 CFR 46, which governs the protection of human subjects involved in biomedical and behavioral research funded by federal agencies. Various states have enacted state-level laws analogous to the Common Rule in order to protect human subjects who are participating in health sciences trials.

Conflicts of Interest

Conflicts of interest can arise at any moment in a health care setting, and if not managed properly, they can affect patients and overall standard of care. Conflicts occur when a health professional’s personal interests incentives or influences the discharge of his/her professional responsibilities. A health professional may sometimes find themselves in a position where their obligations from one role conflicts with the obligations of another role. The APTA (American Physical Therapy Association) examples a health professional may have, such as physical and emotional, academic, business and research partnerships. When these roles have conflicting interests, the professional may face a conflict and draw the attention of the patients and the board. Some common examples of conflicts that may arise in the health care profession are: If a physical therapist prescribes for a patient they know to be a family member . If there is a family member using a medical laborotory for their own private business. If there is a non-ownership, referring profressor doing significant consulting work for a company whose product professor is recommending. Physicians who are making recommendations about a drug or device but have been on the company payroll to do clinical studies for that devic.
There are steps you can take to identify if a conflict is occuring. First, there are many resources available where you can test to see if there is a conflict. You may also visit with your office counsel but remember that the office counsel is there for the company and not you personally and they may not separate the two. You can examine the circumstance closely and ask yourself if you have some type of interest in the product and if there is any potential for personal gain. If managing a conflict of interest is not an option, the health professsional should decide which obligation will take priority, as each situation is unique.

Cultural Competence and Bias

Addressing cultural competence and bias.
To improve patient outcomes and advance health equity, it is important for health professionals to understand the influence of sociocultural factors on the designs of health services, and to be able to recognize and address biases in health (including systems of privileges and oppression). For example, according to the National Institute of Health, "The social and environmental conditions in which people are born, live, learn, work, and play can be critical determinants of their health. Places of residence may not provide resources that people need to be healthy. Individuals may lack access to cleaner air and water, a good education, or nutritious food. At the same time, stressors in daily life—such as discrimination and violence—can make people more susceptible to a host of illnesses."
Health professionals should be trained to acknowledge any bias they may have about certain groups of people and how this bias may affect treatment of patients within these categories and how to tailor treatment to be considerate of all differences. Several national organizations offer webinars, workshops, and conferences to help health professionals better understand implicit bias and develop strategies to mitigate the effects of biases.

Legal Ramifications of Technological Innovations

As the healthcare industry increasingly adopts new technologies, practitioners face a host of legal challenges and ethical dilemmas in navigating their implementation. Just as technological advances transform the delivery of care, so too they introduce or expand the legal issues that healthcare professionals must contend with.
The rapid adoption of telemedicine raises several legal considerations, such as state licensure requirements, reimbursement eligibility, and confidentiality concerns. For instance, physicians providing telehealth services must be licensed in the state where the patient is located at the time of the consultation. As a result, physicians or other healthcare professionals providing virtual care to patients across state lines may face the prospect of needing separate licenses, which can be time-consuming, costly, and complicated. Some states have enacted specific telemedicine legislation that creates more streamlined licensing requirements for telehealth providers. Other states may grant exceptions to the licensure issue for consultations with patients traveling or visiting within the state, or for providing a second opinion.
In addition to state licensure, the terms of reimbursement from insurers for telehealth visits vary. Commercial insurers may only reimburse telehealth visits that are comparable to traditional office visits, and may limit their reimbursement to encounters within certain clinical specialties. With respect to Medicaid and Medicare reimbursement, federal laws regulating professional conduct and self-referral by physicians and other healthcare professionals can affect the provision of telehealth services. For example, the federal Anti-Kickback Statute generally prohibits remuneration to induce the referral of federal program business, and contains an exception from the prohibition for certain services provided through a telehealth network. Similarly, the federal Physician Self-Referral Law, also known as the Stark Law, generally prohibits physician self-referrals to entities in which they or their immediate family members have an ownership or investment interest, but contains a Stark Law Exception for certain ancillary services furnished by a physician through an arrangement with a designated health services entity if certain conditions are met, including that the services are furnished through a telehealth network.
Another technology-related issue that is becoming increasingly prevalent in the professional practice of health professions is the use of electronic health records (EHR), which can range from vendor-supplied software to cloud-based systems hosted by third-party providers to software developed and built in-house by institutions or individual professionals. Providers must carefully adhere to privacy and security requirements applicable to the use of EHR and must ensure that their use of EHR is consistent with the standards of care when documenting encounters in such records. Institutions that develop, deploy, host, or implement EHR systems may also face issues related to the scope of care provided, the safety and security of patient health information, configuration and maintenance of systems, and the usability and accessibility of such systems.
Furthermore, as healthcare providers increasingly turn to artificial intelligence (AI) solutions in diagnosing and recommending treatment for patients, various legal issues may arise. AI-based diagnostic technologies may affect the standard of care in diagnosing or treating a patient or conflict with other applicable standards, such as those in the area of informed consent. The use of AI technologies in healthcare settings may also present significant issues related to data security, particularly with regard to protecting the confidentiality of patient privacy.
In sum, the integration into the professional practice of health professions of new technologies such as telemedicine, EHR, and AI will continue to pose significant challenges for health professionals, who should stay abreast of the evolving state of the law in this area.

Emerging Trends in Legal and Ethical Challenges

As the health professions continue to evolve and expand the parameters of patient care, the legal and ethical challenges they present will most certainly follow suit. For example, the past decade has seen an increase in regulatory oversight at both federal and state levels, leading to greater scrutiny of medical practices and billing procedures. While the scope of that "oversight" is often a point of contention between government and health practitioners, it can’t be denied that increased regulatory oversight has added, and will continue to add, to the time and costs associated with normal insurance proceedings, licensure, hospital credentialing, etc.
Additionally, technological advances in testing and patient monitoring are driving the need for significant regulatory changes. Consider , for example, the emergence of on-the-spot genetic testing. Not only does this change the way healthcare is delivered and compensated (insurance does not yet cover this for common applications), but also presents new ethical dilemmas for practitioners and their patients, such as who owns the data generated and the right to privacy.
The ongoing threats posed by outbreaks such as SARS and H1N1 will also drive decisions about the future of clinical practice and legal supervision of advances in patient care. Whether and to what extent healthcare insurers will provide coverage for viral pandemics is an existing and ongoing question. Providers who offer healthcare to a broad range of clients, therefore, will need to consider all of these issues in the development of their business and patient care strategies.