With the wake of pandemic and hard-working medical professionals who are providing inordinately marvellous services risking their lives, few medical malpractice cases have also come up, therefore the need for robust medical laws has increased. As we know the Covid-19 crisis is pandemic for people but an opportunity for few mafias and business entities as well.
Cases are seen in the past few months of Covid-19
- Private hospitals are getting huge AID from government, but they were unable to deliver that level of the facility to patients, Some hospitals are overcharging fees as single day ICU charge for Covid-19 positive patients, there have been cases where Few COVID-19 patients also committed suicide during the isolation.
- It is evident Practically at the ground level, there is lack of safety equipment for doctors, health care workers as well as patients, few hospitals do not bother to even change bedsheets of COVID-19 ward and care for basic sanitation There is also a severe scarcity of nursing staff and doctors because no one is willing to work without protective gear.
- Government doctors and medical students risk their life to treat an infected patient without getting good quality PPE kit which has very less protective efficiency, for this, huge funds have been allocated on the ground level and already received for treatment from the government but somewhere its unable to reach right people.
- Scientifically unapproved and untested medicines are claiming to be 100% successful in treating COVID-19 without any statistical data or rational-legal evidence, so-called “desi-ilaaj” messages being forwarded on social media without any scientific testing and evidence or proofs.
Other medical malpractice cases
- Medically unqualified people practising allopathic medicine treatments and treating patients irrationally, some PHC don’t have facilities of basic investigations and surgical procedures, so even if qualified doctors are appointed they are handicapped without a lab and other support staff and facility.
- Female infanticides and child gender determination are still happening especially in few rural areas, Illegal sale of human organs especially in transplantation cases., Human physical and mental harassment by the name of magic for treating diseases.
- A very few MBBS are willing to work in a set up where fewer facilities are available so non- qualified workers started recommending allopathic medicines, Some Govt. medical professionals just for a commission, refer patients to private and expensive hospitals, some times overcharging of fees without even providing receipts is also done.
- Some people do USG in the periphery who are not even entitled as Radiologists, most of the surgeries are done without anaesthetists for cost-cutting, and minor surgeries are done by technicians who are the assistant of surgeons.
- Some Surgeons and Gynecologists refer patients for operation at government hospitals and do surgery with government hospital’s assets but charge a high fee as their own private practice.
- Machines such as MRI, C.T Scan, X-ray, etc at some Government hospitals are not in working condition because the Radiologists and technicians are being commissioned by outside private diagnostic centres
- Doctors have also being tortured and assaulted both mentally and physically, mostly they become victims of false and irrational allegations.
Despite the Laws against medical malpractice, its implementation is not seen due to the inactiveness and ignorance of law enforcement agencies at ground level. When we talk about the reason for such medical malpractice cases, the most popular reasons are illiteracy, lack of awareness, false assurance by mal-practitioners, limitation of administration, and law enforcement authorities.”The government can provide funds and facilities but real treatment lies in the hands of ground-level workers”
A look at Medical Laws and Regulations
Even globally, most Physicians aren’t Lawyers. But, they are protected by the law and also they have legal responsibilities towards the people, some highlighted global medical rules and laws are-
HCQIA- The Health Care Quality and Improvement Act of 1986 protects against monetary damages for physicians who take part in the peer review of potentially incompetent physicians. It also created a national practitioner data bank to track unprofessional physicians, and enacted procedural rules for due process, privilege restrictions, and reporting and disbursement of information.
CHIP- The Children’s Health Insurance Program is a partnership between federal and state governments that offers affordable health coverage for children in families that earn too much money to qualify for Medicaid.
Anti-Kickback Act- This act of 1986 prohibits getting paid for referrals when federal healthcare programs like Medicare and Medicaid are involved. Referrals can be for drugs, supplies, or healthcare services, and payments can include cash, free rent, vacation, dining, or excessive pay for consultancy or medical directorships.
HRRP- Hospital Readmissions Reduction Program is a Medicare value-based purchasing program that decreases payments to hospitals that readmit patients excessively. The goal of the program is to link payment with quality of hospital care.CMS tracks readmissions statistics for six conditions/procedures:
- Acute myocardial infarction
- Coronary artery bypass graft surgery
- Chronic obstructive pulmonary disease
- Elective primary total hip arthroplasty and/or total knee Arthroplasty
- Heart failure
PSQIA- The Patient Safety and Quality Improvement Act of 2005 creates a voluntary reporting system designed to improve the data available to assess and resolve patient safety and health-care quality issues. To this end, PSQIA proffers federal privilege and confidentiality protections for patient safety information.
EMTALA- Emergency Medical Treatment and Active Labor Act went into effect in 1986. guarantees emergency health care by requiring healthcare providers to deliver medical services regardless of the patient’s ability to pay.
Stark Law- This Law bars a physician from referring patients to receive Medicare or Medicaid services in which that physician has a financial interest. For instance, a physician referring a patient to a home health business that the physician owns is likely a violation of the Stark law
GINA- The federal government created the Genetic Information Nondiscrimination Act to keep employers and insurance companies from discriminating against people based on their genetic testing—for example, a genetic test for sickle cell anaemia, a disease that afflicts African-Americans.
HITECH Act- The Health Information Technology for Economic and Clinical Health Act 2009 to promote health information technology among healthcare workers.
False Claims Act- This act was passed during the Civil War in response to fraud perpetrated by crooked contractors who were bilking the US military. Today, this statute is known for imposing liability on individuals and companies that defraud government programs such as Medicare and Medicaid
Medical Laws and Legal regulations in India
- Quarantine Rule:
Section 271 of the Indian Penal Code (IPC) deals with the spread of infectious disease which amounts to a violation of the quarantine rule. This law roughly states that the onus to keep surroundings clean and hygienic so as to avoid the spread of any infectious disease falls on the medical establishment.
- Law Governing to Professional Training and Research:
MCI rules for internship training, National board of examinations Rules for DNB training, Nursing Council of India Rules for staring school/college of nursing, ICMR rules governing Medical Research
- Law Related to Governing the Commissioning of Hospital:
Indian medical council Act, Indian medical council (professional conduct, etiquette, and ethics) regulations, Indian medical degrees Act Registration of medical practitioners with state medical councils, Indian nursing council Act, Delhi nursing council Act 1997, The ICN Code of ethics for nurses, AICTE rules of Physiotherapy rules
- Law Governing Storage / Sale of Drugs and Safe Medication:
The drug and cosmetics rules (Amendment 2005) 1945, Drugs control Act 1950, Pharmacy Act 1948, Narcotics and psychotropic substances Act 1985
- Law Governing to Management of Patients:
Drugs and magic remedies (objectionable) advertisements Act 1954, Preconception and prenatal diagnostic techniques ( prohibition of sex selection ) Rules 1996, MTP Act 1997 Transplantation of human organ Act 1994, Transplantation of human organ Rule 1995
- Law Governing The Safety of Patients, Public and Staff:
Biomedical medical waste management handling rules 1998/2000, Rules regarding the safe discharge of effluents in the public sewers / drains DMC sanitation and public health Bye-laws 1959, Environment Protection Act 1986
IPC sections related to medical malpractice
- Drugs – Adulteration of drugs (IPC Sec 274), Sales of adulterated drugs ( IPC Sec 275 ), Sales of drugs as different drug or preparation ( IPC Sec 276 ), Negligent conduct with regard to poisonous substances (IPC Sec 284).
- Miscarriage and Abortion- Section 314 of the Indian Penal Code deals with death caused by an act done with the intent to cause miscarriage. This section concerns anyone including a medical professional, who commits an act with the intention of causing miscarriage which may lead to the death of the woman
- Causing Hurt, Deficiency of Service-In the context of healthcare services, sections 319-322 deal with fault, imperfection, or inadequacy in quality of vision or hearing. These laws also deal with grievous hurt or disfigurement.
- Death by Negligence- Section 304-A of the IPC deals with death by negligence, in this context, the negligence of a medical professional. This law states that if a medical professional causes the death of a person by performing a rash or negligent act, the act will amount to culpable homicide.
- IPC Section 336 – act endangering life or personal safety of others
- IPC Section 337 – causing hurt by act endangering life or personal safety of others
- IPC Section 338 – causing grievous hurt by act endangering the life and personal safety of others
Doctors in India may be held liable for their services individually or vicariously unless they come within the exceptions specified in the case of Indian Medical Association vs V P Santha. Doctors are not liable for their services individually or vicariously if they do not charge fees. Thus free treatment at a non-government hospital, governmental hospital, health centre, dispensary, or nursing home would not be considered a “service” as defined in Section 2 (1) (0) of the Consumer Protection Act, 1986.
Supreme Court of India rulings
In Mohanan vs Prabha G Nair and another case, it ruled that a doctor’s negligence could be ascertained only by scanning the material and expert evidence that might be presented during a trial.
In Suresh Gupta’s case in August 2004 the standard of negligence that had to be proved to fix a doctor’s or surgeon’s criminal liability was set at “gross negligence” or “recklessness.”Supreme Court distinguished between an error of judgment and culpable negligence. It held that criminal prosecution of doctors without adequate medical opinion pointing to their guilt would do a great disservice to the community.
A doctor cannot be tried for culpable or criminal negligence in all cases of medical mishaps or misfortunes. A doctor may be liable in a civil case for negligence but mere carelessness or want of due attention and skill cannot be described as so reckless or grossly negligent as to make her/ him criminally liable. The courts held that this distinction was necessary so that the hazards of medical professionals being exposed to civil liability may not unreasonably extend to criminal liability and expose them to the risk of imprisonment for alleged criminal negligence.
Hence the complaint against the doctor must show negligence or rashness of such a degree as to indicate a mental state that can be described as totally apathetic towards the patient. Such gross negligence alone is punishable.
On September 9, 2004, Justices Arijit Pasayat and CK Thakker referred the question of medical negligence to a larger Bench of the Supreme Court. They observed that words such as “gross”, “reckless”, “competence”, and “indifference” did not occur anywhere in the definition of “negligence” under Section 304A of the Indian Penal Code and hence they could not agree with the judgment delivered in the case of Dr. Suresh Gupta. The issue was decided in the Supreme Court in the case of Jacob Mathew vs State of Punjab
The court directed the central government to frame guidelines to save doctors from unnecessary harassment and undue pressure in performing their duties. It ruled that until the government framed such guidelines, the following guidelines would prevail
A private complaint of rashness or negligence against a doctor may not be entertained without prima facie evidence in the form of a credible opinion of another competent doctor supporting the charge. In addition, the investigating officer should give an independent opinion, preferably of a government doctor. Finally, a doctor may be arrested only if the investigating officer believes that she/ he would not be available for prosecution unless arrested.
What can be done?
- Advance important health policy goals such as Universal health coverage, establish the basis for organizing, governing, and financing a country’s health system.
- Protect the public and social nature of healthcare from communicable diseases or other public health risks and patient rights.
- Regulate the operation of hospitals, safety, and efficacy of medicines and medical devices clinics or other health services; control the training and practice standards of health workers.
- Address non-communicable disease risk factors e.g. smoking also regulates the collection and use of health information.
- Laws on Formulation of Crisis Management Plan for medical malpractices and Conducting regular training and audit for medical workers
- Citizens shouldn’t believe any forwarded medical treatment news blindly, cross-check it from government platforms, Spread awareness about medical laws and medical malpractices
- Hire a medical lawyer, if you are a victim of medical malpractice
- Pay at most respect to doctors who are truly committed to their work and report any assault done to them based on irrational and false allegations.
“Make sure to get the help of Medical Lawyers, if you experience any kind of medical malpractice, also the Doctors can seek the help of Medical Law experts if they have been falsely alleged and assaulted”
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