This article is written by Shreya Singhal of Rajiv Gandhi National Law University, an intern under Legal Vidhiya
Abstract
Medical Law and Ethics are two separate concepts but their domain overlap in many situations. Over the years, several medical laws have been evolved taking into consideration the need of the changing society. As new laws have also been made in the field of medicine, the point of contention that arises is the ethical practice of the medical professionals. Doctors and the other medical staff are given a huge responsibility as they handle the human lives with their knowledge and skills. In such a situation, the ethical obligations of the doctors play a significant role. They are ethically bound to inform their patient if in a conscious state or their families if the patient is not in a condition to give his consent. But sometimes the medical laws come into contrast with these and the other ethical practices. So, what should be valued more- ethics or the laws laid down for the professionals to follow.
Key Words: Medical Law, Ethics, Healthcare
Medical Laws
Medical laws refer to the legal rules and regulations that govern the practice of medicine. Medical laws can be federal, state, or local laws, and they cover a wide range of areas related to healthcare. Here are some examples of medical laws:
- Health Insurance Portability and Accountability Act (HIPAA): The Health Insurance Portability and Accountability Act (HIPAA), a federal legislation passed in 1996, governs how healthcare providers, health plans, and their business partners can use and disclose protected health information (PHI). HIPAA’s main objective is to safeguard the security and privacy of people’s health information while enabling the information flow required to deliver high-quality healthcare.
HIPAA establishes national standards for the privacy and security of PHI and mandates that covered businesses have security measures in place to preserve PHI’s availability, confidentiality, and integrity. Before using or disclosing a person’s PHI, a covered entity must first have that person’s written consent, with some exceptions like treatment, payment, or healthcare operations.
Individuals are also given specific rights under HIPAA with regard to their PHI, including the ability to access, modify, and request an accounting of disclosures of their PHI. Individuals must receive a notice of privacy practices from covered entities that outlines their HIPAA rights as well as the uses and disclosures that will be made of their PHI. HIPAA violations can carry severe penalties, such as civil and criminal fines and penalties, license loss, and in some circumstances, even incarceration. Healthcare providers and their business partners must adhere to HIPAA regulations in order to maintain the confidentiality and security of patient health information and to stay out of legal trouble.
- Patient Protection and Affordable Care Act (ACA): This federal law aims to improve access to healthcare and regulate health insurance markets. The Patient Protection and Affordable Care Act (ACA), also known as Obamacare, is a federal law enacted in 2010 that aims to improve access to healthcare and regulate health insurance markets in the United States. The ACA includes several provisions that expand access to health insurance coverage, improve the quality of healthcare, and reduce healthcare costs.
The ACA has faced significant controversy and legal challenges since its enactment, with critics arguing that it places an undue burden on individuals and businesses and that it is unconstitutional. Despite these challenges, the ACA remains a significant piece of healthcare legislation in the United States, with millions of individuals gaining access to health insurance coverage as a result of its provisions.
- Americans with Disabilities Act (ADA): Discrimination against people with disabilities is illegal under this federal law, including in healthcare facilities. A federal law known as the Americans with Disabilities Act (ADA) was passed in 1990 and forbids discrimination against people with disabilities in the workplace, public places, the transportation system, and other facets of American society. A physical or mental impairment that significantly impairs one or more main life activities, such as walking, seeing, hearing, or working, is referred to as a disability under the Americans with Disabilities Act (ADA).
Employers with 15 or more employees are required by the ADA to make reasonable accommodations for qualified employees with disabilities who can carry out the essential duties of their position. alterations to the workplace, including ramp installation or shift alterations, are examples of reasonable accommodations that help people with disabilities accomplish their jobs.
The ADA also requires public accommodations, such as restaurants, hotels, and transportation services, to provide equal access to individuals with disabilities. This may include providing accessible parking, entrances, and restrooms, as well as offering assistive technology or other accommodations as needed.
In addition to prohibiting discrimination against individuals with disabilities, the ADA also prohibits retaliation against individuals who assert their rights under the law. The Equal Employment Opportunity Commission (EEOC) is responsible for enforcing the ADA’s employment provisions, while the Department of Justice (DOJ) is responsible for enforcing the law’s public accommodation provisions. The ADA has been instrumental in advancing the rights of individuals with disabilities in the United States, enabling greater access and opportunities in employment and public life.
These are just a few examples of the medical laws that govern the practice of medicine in the United States. Compliance with medical laws is essential for healthcare professionals to avoid legal consequences and provide high-quality care to their patients.
Medical Laws in India
In India, medical laws are governed by a combination of federal and state laws. Various cases have happened in India which have attracted the attention of the Indian judiciary as in the case of Saroj Iyer and Anr. v. Maharashtra Medical of Indian Medicine, Bombay and Anr[1] and Nizam’s Institute of Medical Sciences v. Prasanth S. Dhananka.[2] Here are some of the key medical laws in India:
- Indian Medical Council Act, 1956: The Indian Medical Council Act, 1956 is an Act of the Indian Parliament that regulates the medical profession in India. The Act establishes the Medical Council of India (MCI), which is responsible for setting standards for medical education, registration of doctors, and ensuring the ethical conduct of medical practitioners. The MCI was replaced by the National Medical Commission (NMC) in 2019.
The Act outlines the qualifications and criteria for doctors to be registered with the MCI, as well as the standards for medical education and training. It also provides for the establishment of State Medical Councils to regulate medical education and practice in the states.
The Act has undergone several amendments over the years, including the addition of provisions related to the recognition of medical qualifications obtained from foreign universities and institutions. The Act has been controversial at times, with criticism of the MCI for corruption and lack of accountability.
Overall, the Indian Medical Council Act, 1956 plays a crucial role in regulating the medical profession in India and ensuring that medical practitioners meet the highest standards of education, training, and ethical conduct.
- Clinical Establishments (Registration and Regulation) Act, 2010: This federal law regulates the registration and functioning of clinical establishments, including hospitals, clinics, and diagnostic centers.
- Drugs and Cosmetics Act, 1940: This federal law regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India. The law sets standards for the quality, safety, and efficacy of drugs and cosmetics.
- Transplantation of Human Organs Act, 1994: The Transplantation of Human Organs Act, 1994 is an Act of the Indian Parliament that regulates the donation and transplantation of human organs in India. The Act was enacted to address the shortage of organs for transplantation, as well as to prevent commercialization of organ donation and transplantation.
The Act establishes the National Organ and Tissue Transplant Organization (NOTTO) as the apex body for coordination and networking between different organ procurement and transplantation organizations in the country. It also provides for the establishment of State Organ and Tissue Transplant Organizations (SOTTO) and other bodies at the regional and local levels.
The Act outlines the legal framework for organ donation and transplantation, including the definition of brain death and the criteria for determining it. It also lays down the rules and regulations for the consent process, the allocation of organs, and the registration and regulation of hospitals and doctors involved in organ transplantation.
The Act prohibits the sale and purchase of organs and provides for stringent penalties for those involved in such activities. It also provides for the protection of donors and recipients, including confidentiality of their personal information and medical records.
Overall, the Transplantation of Human Organs Act, 1994 plays a crucial role in promoting ethical and legal organ donation and transplantation in India, and has helped to increase awareness and participation in organ donation.
- Mental Healthcare Act, 2017: This federal law is providing for the security of mental health and the rights of persons with mental illness. The law regulates the admission, treatment, and discharge of persons with mental illness and prohibits inhuman treatment and electroconvulsive therapy without anesthesia.
- Consumer Protection Act, 2019: This federal law provides for the protection of consumers’ rights and interests, including in relation to medical services. The law allows consumers to file complaints against healthcare providers for deficient services and seek compensation.
In addition to these federal laws, each state in India has its own medical practice act that regulates the practice of medicine within the state. Compliance with medical laws is essential for healthcare professionals and institutions to provide safe, ethical, and high-quality care to patients and avoid legal consequences.
Interrelationship
Ethics and medical law are closely related but distinct fields that govern the practice of medicine. Ethics refers to the principles of right and wrong that guide human behavior, while medical law comprises the legal rules and regulations that govern the practice of medicine. The relationship between ethics and medical law is that medical law provides a framework for the ethical principles to be applied and enforced in a healthcare setting.
In other words, medical law sets the legal requirements for healthcare professionals, such as standards of care, confidentiality, informed consent, and patient rights. Healthcare professionals must follow these legal requirements to avoid legal consequences, such as malpractice lawsuits or criminal charges. Ethics, on the other hand, provides a moral framework for healthcare professionals to take such decisions that are in the best pursuits of their patients. Ethical principles, such as respect for patient autonomy, beneficence, and non-maleficence, guide healthcare professionals in making decisions that are ethically sound and align with their professional obligations.
Thus, ethics and medical law coexist by providing complementary frameworks for healthcare professionals to practice medicine while upholding their legal and ethical obligations. Healthcare professionals must navigate both ethical and legal considerations to make sure that they provide best care to their patients while avoiding any legal or ethical violations.
Conclusion
Both ethics and medical law are important considerations in healthcare, but they serve different purposes and cannot always be weighed against each other. Ethics are moral principles that guide behavior and decision-making in healthcare, while medical law refers to the legal framework that governs medical practice and the rights and responsibilities of patients and healthcare providers.
In general, it is important for healthcare providers to abide by both ethical principles and medical laws to ensure that they are providing safe and effective care that respects patient autonomy and protects their rights. However, in situations where there may be a conflict between ethics and medical law, healthcare providers should prioritize ethical principles as they reflect the fundamental values of healthcare, such as promoting patient well-being and respecting their autonomy.
For example, if a medical law mandates a certain treatment for a patient, but the treatment is against the patient’s wishes and may cause harm, the healthcare provider should prioritize the patient’s autonomy and well-being by advocating for alternative treatments or discussing the risks and benefits of the mandated treatment with the patient. In summary, while both ethics and medical law are important considerations in healthcare, ethical principles should generally be weighed more heavily as they reflect the fundamental values of healthcare and prioritize the well-being and autonomy of patients.
[1] Saroj Iyer and Anr. v. Maharashtra Medical of Indian Medicine, Bombay and Anr , 2001 SCC OnLine Bom 693.
[2] Nizam’s Institute of Medical Sciences v. Prasanth S. Dhananka, (2009) 6 SCC 1.
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