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Is legal documentation important in medical practice?
  • By: admin
  • Date: 16 Jan 2020
  • Medical Negligence
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Introduction

As a medical practitioner, it is very important that the doctors maintain legal documentation and manage the medical records of the patient properly.

What are medical records?

The medical records include mainly the medical history, the clinical findings, the results of the test carried out, the care administered before operation, the notes which are taken down during the operation of the patient, the care taken after the patients operation is complete and the daily progress of the patient, and also the medications which are prescribed to the patient.

Consent

The consent which is acquired through legal means shall be very helpful to the doctor in the long run. For example consent for major or minor operations or for starting a new course of treatment for the patient’s betterment. And it is the duty of the doctor to acquire consent as per the principles of valid consent which are laid down for reference under the Indian law. Therefore, it is important that the medical staff and other officials at the hospital must be trained in maintaining the medical records of the patient in a systematic manner.

Indian medical council and record-keeping

 

All details regarding maintenance of medical records have been given under the Medical Council of India regulations 2002, and the regulations have laid down certain guidelines with respect to the number of years the medical records of the patient has to be maintained. They are as follows:

  1. Every doctor must maintain the medical records of the patient for a minimum period of three years from the date of the treatment of the patient.
  2. If a request would be made by the patient or the legal authorities of the court to produce the documents, the medical practitioner shall submit the same within 72 hours, and if the medical practitioner refuses to submit the documents, it might lead to serious consequences.

 

Reasons why medical documentation is important

 

There are two important reasons why there is a need to maintain the medical records of the patient. They are:

Seamless evaluation of the patient: Maintaining medical records of the patient will be helpful for analyzing and evaluating the patient’s profile and it will also help in analyzing the course of the treatment and the results. It will determine whether the health of the patient is improving or deteriorating and to what extent. It will also assist in planning out future procedures.

Legal documentation: It is always useful in cases where the medical practitioner has been alleged of medical negligence in the court of law. However, it can only be used in the form of documentary evidence when called upon to produce the same. The medical documentation becomes very important while pronouncing a judgment in favour of the medical practitioner. And it shall be helpful in cases with regards to a medical insurance claim with respect to medical negligence from the doctor’s end.

 

Essentials of managing medical records

 

  1. Comprehensive: Simple language should be used while recording the data and it should be easily understood by an individual. This step is important for planning, policy-making and making decisions for the patient or for the betterment of the hospital.
  2. Proper planning: The medical records must be looked at regular intervals during the working hours of the hospital or the clinic. One must rule out the information from the database of the medical records, which is not required for future reference.
  3. Cost-effective way: It is always important that one must maintain the medical records of the patient in a cost-efficient way (electronic records) where no loss is incurred to maintain the medical records of the patients for future reference.
  4. Fully accurate: The information which is going to be recorded should be confidential and true in all aspects.

 

Conclusion

 

It is the duty of the doctors to maintain the confidentiality of the medical records of the patient. However, in cases of medical negligence; it becomes important to produce the documents in the court of law. If the medical reports, at the time of submission in the court, are well maintained by the doctor, it may be an added advantage to the doctor or any other medical practitioner during the legal proceedings. These legal documents maintained by the medical practitioner hold an evidentiary value.

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Why do doctors need to be updated with medical negligence laws?

By: admin Medical Negligence 16 Jan 2020

Introduction

The medical profession is considered as one of the noblest professions in the world. The professionals in this area of practice are capable of serving humanity, provide care, efficiency and render professional skill while treating their patients. However, nowadays due to the communication gap between the doctor and the patient or due to the profit motive-oriented profession, the cases of medical negligence is increasing day by day. Thus, there are some lacunae in today’s medical treatment and professional expertise. Therefore, in order to safeguard oneself from the strict laws which are in favour of the patient, it is important to know the medical laws with respect to medical negligence so that they can protect themselves from the case which is registered against the doctors if they are not guilty of committing such an offence.

Since the time public awareness has spread in India regarding the types of cases which fall under medical negligence and the actions that have been taken against the medical fraternity, the hospitals and the doctors are facing a huge number of legal complaints with regards to even petty matters of medical negligence. Therefore, it is essential for a doctor to know what actions amount to medical negligence in India.

It is also expected from the medical professional that they follow the code of medical ethics which has been laid down by the Indian Medical Council which also provides the duties towards the patients which has to be fulfilled by the doctor.

 

Reasons why a doctor must be updated with medical negligence laws

 

  1. A doctor may be called upon in the court of law and may be questioned regarding the alleged medical negligence through which harm has been caused to the patient.
  2. Even if the doctor is summoned to the court, the burden of proof lies upon the applicant who has filed the case against the doctor. However, it is also better if the medical practitioner has the knowledge regarding the provisions of the law with regards to the burden of proof and how he can safeguard himself from the medical negligence case that has been filed against him/her. The doctor can hire a legal person who can explain the law to the accused doctor.

 

Medical negligence case is a legal case that can be defined as a case injury which is caused due to the malpractice of the doctor while treating the injury of the patient for which the patient had approached the doctor.

The cases that fall under the purview of the medical negligence cases are as follows:

  1. Misdiagnosis of an ailment of the patient.
  2. Incorrect medication prescribed to the patient.
  3. Mistakes during surgery, for instance, leaving a piece of equipment in the body of the patient.
  4. Fake doctor treating a patient.

Therefore, it is very important for the doctor to have the basic legal knowledge, especially with regards to cases which requires police investigation as well as for cases where the doctor is accused of medical negligence in India.

 

Laws which the doctor must know

 

  1. The Indian penal code
  2. Criminal procedure code 1908
  3. The Consumer Protection Act
  4. Medical negligence as per the Indian Medical Association.

And such laws which are decided by the Indian Medical Council from time to time.

 

Conclusion

 

To conclude, it is said that the medical profession with special reference to the doctor, must be aware and up to date with the recent rules and regulations that deal with cases of medical negligence. It becomes essential for the doctor to maintain the medical records and the history of the patient so that such records can be produced in the court of law when a case of medical negligence arises.

In order to change the current landscape of the Indian Healthcare System, the government is constantly trying to tackle the challenges faced in an overpopulated country. As per news updated on 16th September 2019, there are certain rules set to keep track of doctors and hospitals through maintaining a complete record of all the medical professionals practising in hospitals, in order to hold them accountable for their wrong-doings, through the National Medical Commission Act. Hence, now more than ever, doctors and other medical professionals are required to be updated with the changes in the law.

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Does telephonic consultations amount to culpable negligence?

By: admin Medical Negligence 08 Jan 2020

What is section 304 of the Indian Penal Code

The section states that whoever commits culpable homicide not amounting to murder shall be awarded imprisonment for life or for a specific term which may be extended up to 10 years and also fine may be imposed on certain cases. It is a non-bailable offence. There are two parts in this section:

First is when an act is done with the intention of causing the death of that particular individual or causing bodily pain or injury which may result in the death of the person then they shall be awarded imprisonment with up to 10 years or more depending upon the discretion and decision of the judge in a particular case.

Secondly, when an act is committed, with the idea that the act may result in death, but not with the intention of causing death(or to commit an act that may directly result in the death of the person).

 

Telephonic consultation by doctors resulting in culpable negligence

 

It is important that the doctors should note that prescribing medicines via telephonic conversation to the patient without diagnosing the problem from which the patient is suffering may result in culpable negligence under section 304 of the Indian penal code.

In today’s times, it is always better that all medical practitioners follow a prescribed set of standard care treatment which they shall provide to the patient so that the medical practitioner does not get punishment with respect to any form of medical negligence as the laws are strict towards the medical practitioner and hence, it is always better to follow the prescribed norms which shall be as per laws.

An error in diagnosing the patient’s health issue shall come under medical negligence under section 304 but, in the case of prescribing medicines without diagnosing the patient’s health issue will result in culpable negligence.

 

Cases

 

  1. Doctor Jacob Mathew’s Case

In this case, the Supreme Court stated that if a doctor has to be made criminally liable for the patient’s death it is very important that the patient or the relatives of the patient must prove that the doctor was incompetent in performing the task or he/she was negligent towards the patients’ health. Whereas cases which are filed under the civil liability, mere compensation is awarded to the victims of medical negligence.

The Supreme Court has laid down certain guidelines as to when an action be taken against medical practitioners with reference to medical negligence, they are as follows-

  • In cases of the error caused while judging the best alternative treatment that could be done in the case. The doctor cannot be accused of culpable negligence in such a case.
  • The medical professionals shall be held liable if they do not possess the requisite professional skill.

 

  1. Martin F D’souza Vs Mohd Ishfaq Case No- 3541 of 2002

In this case, decided by the Supreme Court of India, the two-bench judge explained certain precautions which should be taken by all medical practitioners so that they can protect themselves from complaints which arise due to medical negligence. Further, it lays down that telephonic conversation is under the preview of culpable negligence and one must not prescribe medicines on phone without properly examining the patient.

Sometimes, the telephonic consultation may save time and is more flexible in terms of accessibility as it is more convenient for both the doctor and the patient but it is important that the doctor must arrange a face to face meeting if the condition of the patient is not improving so that there is efficiency in the treatment and the method or the medicines can be changed timely.

The medical practitioner can also record the conversation that is happening between the doctor and the patient with the prior approval of the patient. So, it can be used as proof in case a matter involving culpable negligence arise.

It is important that all medical practitioners maintain all medical records and important data regarding the patient’s health and maintain the confidentiality of the same. It should also be the duty of the doctor to make sure, the information about the patient shouldn’t be shared with anyone.

In cases where the medical practitioners do not follow the rules laid down, it may sometimes lead to medical negligence and charge sheet may be filed against the doctor committing the act.

 

Protection from medical negligence or culpable negligence

 

  1. Meeting the standard care treatment method: The medical practitioner can keep himself up to date with the latest standard care treatment so that the health of the patient is not hampered, and so that it improves through the latest treatment methods which in turn will help the medical practitioner to avoid cases arising out of medical negligence or culpable negligence.
  2. Maintain proper documentation and health records of patients with that of prescribing medicines: It is always better to maintain a record of everything including the medicines that are being prescribed to the patient for improving the health condition. This step will face difficulty in execution in terms of telephonic consultations to maintain a record. And also, the conversations between the doctor and the patient, which can be used as evidence in the court of law if required in future.
  3. The doctor must engage in an interactive session with the patient:It is important that the doctor must speak to the patient and take prior permission before starting any treatment and also it is the duty of the doctor to explain the risks involved and the method or the process in which the treatment will be carried out by the doctor. This must also be recorded in the form of a document or in any other format.

 

Conclusion

 

Thus, if the medical practitioner is prescribing medicines to the patient on call, it would be the duty of the professional to record the conversation and maintain proper documentation of the treatment that he is giving to the patient on call so that he can protect himself from the cases of culpable negligence and as well as medical negligence. This will help the doctor to produce such documents as a part of the evidence in the court of law. The medical professionals shall discharge their duties and responsibilities with the utmost care and shall be careful while giving treatment or performing any minor or complex surgery.

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Consumer dispute Redressal Forum in dealing with Medical Negligence

By: admin Medical Negligence 08 Jan 2020

On 24th December 1986, the Consumer Protection Act (COPRA) had been established by the government of India to safeguard the rights and interests of the consumers. However, this act was later modified, and new clauses were added and amended to provide better protection to the consumers in general. This article is going to elucidate certain concepts relating to medical negligence and its involvement under COPRA.

 

Who are consumers?

 

The consumers with relation to the medical industry are:

  1. The patient who pays the doctor for availing the services.
  2. Either of the spouses, parents or any other family relatives.
  3. The legal heirs or the legal representatives of the patient.

 

It was only after the landmark judgment given by the Supreme Court in the case of Indian Medical Association Vs V. P. Shanta that the medical industry and the medical professionals were brought within the ambit of the Consumer Protection Act 1986 under section 2(1)(o) of the Act.

The relationship between a doctor and a patient is completely based on trust and confidence. In the course of the treatment, if the doctor violates any of his/her duties, it amounts to medical negligence by the doctor.  Thus, it is important for the doctors and the patients to know the rules and regulations laid down through the various landmark judgements of the Supreme Court and other such provisions laid down through COPRA in order to safeguard themselves.

 

How can a patient approach the consumer forum

 

The consumer has the option to approach the consumer forum for exercising speedy redressal of medical negligence cases or they can also file a criminal case against the medical practitioner. The consumer must note that in order to file a consumer case under  medical negligence, they must be ready with the following documents:

  1. The prescription, the bills and the references given by the medical practitioner.
  2. One must maintain the medical history records before filing the case in the consumer forum.
  3. It should also be noted that the consent which is given by the patient or the relatives can also be used as evidence in the court of law.

 

Role of consumer dispute redressal forum

 

The Medical Council Act has enlisted provisions to control the negligent acts of medical practitioners in cases of medical negligence. The Indian Medical Association (now, the National Medical Commission) has the right to take disciplinary actions against the medical professionals, who have committed such an act.  Therefore, the consumer dispute redressal forum or the consumer court works as an additional remedy through which compensation is given to the consumers, in this case, patients and their representatives.

The consumer redressal forum, may or may not give the judgment in the favour of the consumer.

There is no specific set of the rules laid down for the consumer dispute redressal forum or the court with regards to medical negligence in India. However, it is high time to make guidelines that the consumer courts have to follow in cases of medical negligence so that the cases of medical negligence are disposed of faster with appropriate compensation and justice to the consumer.

Even in cases of medical negligence under the consumer court, the court says that the burden of proof lies upon the patient or his family. For filing a medical negligence case, it is important to prove that the patient was treated wrongfully by the doctor.

 

Conclusion

 

In the light of recent events with relation to medical negligence, it is important to note that the consumer court should establish specific set of roles for themselves so that if patients approach the consumer forum or the court, then it would be the easier for the patients to determine whether their case stands a chance for speedy redresses of dispute, also, these guidelines will provide certainty. The consumers in the case of medical negligence should make a note that only compensation or monetary gains are awarded to them under COPRA and not imprisonment and other such punishments.

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Promotion of Medical Products.

By: admin Medical Negligence 30 Dec 2019

Department of Pharmaceutical asks industry to regulate promotional practices

The department of pharmaceuticals held a meeting on 23rd December, 2019, to look into the implementation of the uniform code (uniform code means a similar set of rules and regulations which shall be laid down for all pharmaceutical companies with regards to the marketing methods for selling their medical products) for pharmaceutical marketing practices which shall be adopted by all the pharmaceuticals companies. The pharmaceutical companies offer free medical samples to various medical professionals and therefore, the department of the pharmaceutical company regulates the ways of marketing their medical products and conducts the promotional practices as per the due process of law. This meeting was held to review the marketing practices of the pharmaceutical companies which shall be adopted by the Pharma companies.

The promotion of medical products should always be done in an ethical manner and they should introduce the medical products which shall be helpful for the treatment of a specific set of diseases.

 

Complaints against unethical marketing practices

 

Many complaints have come up regarding the illegal and unethical practices to promote a medical product and therefore, the department of pharmaceuticals has been set up to keep a strict watch on the violations made and as well as keeping an eye on the marketing practice.

 

The direction given by the secretary of the department

 

The Secretary of the Department of Pharmaceuticals has directed both the domestic and international Pharma companies that they should strictly comply with the code of ethics provided by the Indian Medical Council. A lobby group has also been created by the department of pharmaceutical where they can share comments and issues which they are facing weekly.

The meeting was conducted by the chairman of the Department of Pharmaceuticals Company shall also be chaired by the chairperson of the National Pharmaceutical Pricing Authority and also with other senior officials of both the departments.

 

The unethical method of marketing practices

 

The recent study by a non- governmental organisation ‘Saathi’ mentioned that their promotional methods still lack the proper conduct of marketing practices according to them as the medical representatives revealed that the Pharma companies bribe the medical practitioners directly or indirectly. For example: by giving them the bribe of foreign trips, expensive smartphones, jewellery and even tickets to entertainment events can be considered a form of bribe and any such other materialistic bribes to the doctors and the other medical staff.

 

Legal framework

 

The medical representatives of various pharmaceutical companies also reported that there was extreme pressure on them for achieving high sales target for their Pharma companies. Thus, the bribing practice shall be strictly regulated by the Indian Medical Council Regulations, 2002. The complaints of such malpractice have been sent to the department of pharmaceutical.

The department of pharmaceuticals has been striving since the year 2016 to draft and implement strict regulations for some marketing practices which should not give gifts or any sort of benefits to the medical practitioners due to which they may promise to prescribe such drugs to their patients. It was also initiated to draft transparency of the marketing practices which shall be carried out for the products.

 

Foreign laws

 

The Canadian government has drafted specific guidelines and also has laid down criteria for the licensing of various products which also includes medical products. The Canadian government also states that while advertising products give some profits to the company which is involved, the company cannot advertise false claims and should not mislead the consumers, and also the Pharma companies should be more careful as many lives are at stake when it comes to medical products and its effectiveness in treating diseases.

 

Conclusion

 

Despite initiating the code for regulating the marketing practices for Pharma companies and even after respective amendments made in the year 2015, still, the unethical way of marketing Pharma products haven’t changed a bit. The code made for protecting those marketing practices has failed to deter such marketing practices, and therefore guidelines can be laid down for marketing the medical products in a similar way as in the case of other countries.

If the pharmaceutical companies violate the rights of the medical practitioners in totality, then the department of pharmaceutical will make it compulsory for everyone to follow the rules and regulations, as discussed in the meeting and strict penal provisions shall be implied for those individuals who violate the laws which are made for governing the marketing practices for medical products in India and also internationally.

Therefore, it is a need to enact new laws for regulating the promotional methods of medical representatives, and so that rights of the medical practitioners are also protected and strict penalty shall be imposed on the individuals or the company who tries to achieve their sales target through unethical methods of marketing practices in India. A uniform set of guidelines should be established by all the companies until an act is not formulated.

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Doctors’ Bill: Prohibition of Violence & Damage to Property Bill, 2019.

By: admin Medical Negligence 30 Dec 2019

Introduction Of The Bill

In Kolkata, the patient’s family members allegedly attacked a doctor in the hospital and because of this; the resident doctors went on strike in support of their colleague. After this incident, there was a need to pass a bill.

A Prohibition of Violence and Damage to Property Bill, 2019 was drafted by the Health Ministry. The Bill proposes that anybody causing grievous hurt (under section 320 of IPC) to a doctor or any other healthcare professional would be imprisoned for up to ten years. The proposed bill also mentions that “all offences under this Act are cognizable and non-bailable”, but the offence under section 5(1) conveys minimum sentence of six months. Under section 9 (1)(i) of the bill, the compensation for damaged property has been based on fair market value.

The Ministry introduced the bill in the last session of parliament. The Health Services Personnel and Clinical Establishment (Prohibition of Violence and Damage to Property) Bill, 2019 intends to punish patients for unlawfully assaulting medical practitioners for up to10 years.

Rejection Of The Bill

 

After the bill was introduced in the winter session, the whole medical fraternity was waiting for the bill to be passed. Doctors have been facing violence due to the increasing issues of medical negligence.  However, due to certain objections, the bill was dismissed.

The Union Ministry of Home Affairs (MHA) during inter-ministerial consultations, stated that India has no separate laws for a particular profession such as lawyers or teachers. If the government of India passes this bill, it gives altogether a different status and law for the doctors, thus leading to chaos and partiality towards professions. They further added that every profession in India has some loopholes, and there can be better ways to handle them instead of demanding a new law. It was also considered that, if this bill gets passed, other professions would ask for the same from the government, leading to unnecessary laws and bills. Further, a senior from the MHA added that the IPC(Indian Penal Code) and CrPC (Criminal procedure code) are sufficient to deal with such issues. The bill was rejected by the MHA.

At the 20th convocation ceremony of National Board of Examinations, AshwiniChoubey stated that the government is troubled over rising instances of attacks on doctors on duty.

Bill Will Be Resent

 

The bill was made by an eight-member sub-committee comprising of officials and representatives of the Medical Council of India, Indian Medical Association, the all India institute of medical sciences and an experienced person from the Bureau of Police research and development.

The Union Health Ministry, Harsh Vardhan, stated that the bill was still under discussion and was not put on the back burner by the government. Senior Health Ministry stated that they would pursue it. We will resend the bill to the government.

It was also noted that the bill was specifically made for healthcare professionals, including the doctors, medical students, paramedical staff and also the diagnostic service providers and the ambulance drivers.

Although the points put up by MHA seem true, one cannot overlook the demand for comprehensive central legislation to put a check on the increasing violence against doctors and other healthcare professionals.

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Why less Indemnity cover is risky for Doctors?

By: admin Medical Negligence 30 Dec 2019

Negligence cases against medical professional are on the rise. Many instances of medical negligence have come into notice in recent years. It is believed to have a surge of 400%, from which certain cases have been solved by the Consumer Protection Act (CPA) since 1994. In this medical negligence cases, the compensation which is directed by the courts is usually in the denominations of lakhs and even Crores. At times, it is the relatives of the patient who file such cases. According to MrMahendrakumarBajpai, an advocate of the Supreme Court, “ cases of medical negligence have been doubled since the year 2014 as more and more people are challenging doctors expertise.” Further, a survey conducted in the year 2013, states that around 5.2 million medical-legal cases have been noticed.

The courts are becoming consumer-friendly, which means more and more cases, are disposed of in the favour of consumers. Therefore, it has become a sheer need to provide insurance coverage to the doctors.

 

Protection To Doctors

 

In the current situation, it has become necessary that doctors protect themselves against frivolous lawsuits. The tension and embarrassment that comes through such lawsuits is something which an individual can’t ignore. The only solution doctor has right now is to minimize the financial risk that comes along these lawsuits. Compensation that arises in such cases is extremely high, and therefore, through an Indemnity Insurance, the doctors can set aside the financial drawbacks through these lawsuits.

 

What is Indemnity Insurance?

 

Indemnity Insurance is a type of legal agreement where both parties agree to certain pre-defined terms and conditions. This is a contractual agreement which should be in written form and duly signed by both the parties. It is designed in such a way that safeguards the interest of the professionals against paying huge compensations. This kind of insurance not just covers the compensation amount, but it also covers up the legal remuneration such as the fees given to lawyers. More the amount of Indemnity Insurance, more are the chances of less risk in the future. In simple words, risk reduces as the amount of insurance increases. The type of Indemnity Insurance also depends upon the type of doctors. Mostly, Indemnity Insurance agreements are valid for 12 months. After every 12 months, a new agreement has to be formulated.

The threat of litigation is so high that certain corporate and private hospitals have made it compulsory for the doctors to avail Indemnity Insurance before they join as a consultant in the hospital.

 

Will Indemnity Insurance Benefit The Doctors?

 

Recently, a panel formed by the Government of India revealed that out of all the cases filed for medical negligence, only 15% of the cases were genuine. Despite this, the amount of compensation and the number of cases both are on the rise. Medical negligence cases have created a serious threat in the medical fraternity. As under such circumstances, mostly, the degree of power is in the hands of the patient.

Therefore, it is always advisable to be prepared for such circumstances. As it is said, “Precaution is always better than cure”.

 

Few Benefits Of Indemnity Insurance:

 

  • Insurance can be altered mid-term. The amount of insurance can be increased or decreased as per the doctor’s requirements.
  • Hassle-free documentation.
  • Indemnity Insurance covers a large area; from compensation to legal fees incurred. Insurance covers losses as well as risks.

 

Cases Where Huge Compensation Was Awarded

 

  1. KunalSahavs AMRI case

This complaint was filed by KunalSaha for his wife, AnuradhaSaha who died at the age of 36 due to the sheer negligence of doctors in Kolkata.

Itis one of the most significant case law pertaining to medical negligence in India.KunalSaha, a doctor by profession himself, filed a case against the doctors of AMRI hospital in Kolkata. However, after his petition was dismissed in Calcutta High Court and West Bengal Medical Council, he went to the Supreme Court of India. After a proper investigation, the Supreme Court directed the hospital and the doctors to pay a compensation of Rs. 5.94 crores along with interest, i.e. Rs11 crores. This is the maximum amount that has been awarded as compensation for medical negligence.

 

  1. Delhi based case

Recently, in Delhi, a hospital was directed by the apex Consumer Court to pay a compensation of Rs. 8 lakh to the widow of a private school teacher. The reason of this compensation was that the hospital without a proper health checkup discharged the patient which led to her death within a few days.

 

  1. AIMS case

A few years ago, the All India Institute of Medical Sciences was directed by the Supreme Court of India to pay a compensation of Rs. 5 Lakh to the patient after it was observed that a doctor wrongly diagnosed a woman with cancer and surgically removed the affected part.

 

Conclusion

 

As mentioned above, there are a lot more cases where medical negligence gets proved by the complainant, and then the doctors or the alleged hospital pay a huge amount of compensation. Due to this unreasonable increase of medical negligence cases, it has become very important that doctors start enrolling for Indemnity Insurance which will make sure that at least the financial losses are minimized. Further, it is advisable to take the help of a lawyer who is experienced to make such agreements and who can explain the legal consequences.

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Virtual Clinic

By: admin Medical Negligence 01 Nov 2019

Virtual Clinic is a technology backed initiative providing a platform for cloud-based unified health record and virtual interaction with doctors and patients through audio and video communication. It is a planned contact by the health care professional responsible for care with a patient for consultation, advice and treatment planning. Virtual Clinic is a social initiative by the Asian Health Meter. The user interface is a tablet PC. The platform of Virtual clinic provides the dashboard of all specialists in the district with a detailed description of their clinical expertise so that patient can choose the specialist on the basis of experience and proximity. It is a web-based technology which aims to provide a scheduled appointment with the doctor for consultancy.
 
In rural India, the patients get affected due to the non-availability of doctors for treating them with prompt and accurate diagnosis. In spite of huge efforts by the government, it had become almost impossible to reach specialist care to the rural population. The main purpose of initiating virtual clinic is to provide quality health care services.
 
The benefit of the virtual clinic is that it is possible to leverage the expertise of specialists who are not available nearby; it promotes the extensive outreach of specialist. It saves the transportation time along with the cost of transportation. The advantage of the virtual clinic is that it is available on a fingertip, convenient for both doctor and patient. Because of convenience, frequent consultation will improve the outcome in chronic illness like heart failure, diabetes and respiratory failure.
 
The growth in the concept of the virtual clinic is likely to lead medico-legal and ethical challenges in India. The challenges include the confidentiality of patients, the standard of treatment, consent from patients, professional misconduct, credentials of doctors, licensure, reimbursement, penalties and liabilities as per the various prevalent laws. The challenges may adversely affect the acceptance and adoption of a virtual clinic consultation.
 
Cons of virtual clinics:
Virtual Clinic has some downsides because of its virtual nature as it requires infrastructure and technical training. It may reduce the direct interaction of the patients with doctors without the impersonal interactions and to make a complete diagnosis; the physical examination needs to be done.
 
Once the relationship between doctors-patient is established, it is doctors responsibility to provide treatment and due care. It raises the two important questions as follows:
 
Can a physician be sued for medical malpractice in operating a virtual clinic?
 
Can medical practitioners be protected by medical indemnity insurance?
 
All medical practitioners must maintain and establish the duty of care to clarify the responsibility of the patient as well as other health care providers. The roles and responsibilities of healthcare professionals should be clearly defined with respect to various aspects and extents.
 
In-country like the US, the virtual clinics allow patients to connect with a healthcare provider through text, video chat or telephone. The medical services in the virtual clinic include consultation, tests and online prescribing.
 
Services of Virtual Clinic limits to patients with the same province or territory, but to interact with them in a different jurisdiction, it is necessary to consider whether the telemedicine license is required or applicable. The requirement for licenses varies from provinces and territories.
 
The ethical and legal obligation of the physician is to protect the personal health information of the patient. The virtual clinics satisfy that the security protocols of information transmitted electronically, including video call, chat, text messaging, etc. Each of these has unique privacy challenges covered. In order to provide services, the jurisdiction where the patient is located is a must.
 
The method of delivering care through a virtual clinic presents unique challenges in obtaining consent from the patient. Some additional consent requirements are recommended while using telemedicine and virtual care. It may include the information of the patient where physicians are located, what is the status of their license, how is the privacy of the patient is managed and all about personal health information.
 
It is essential that medical records are made and maintained for any patient through the virtual clinic. The information of the patient’s medical history and clinical interactions is vital to maintain as the medical records are the legal documents that can be served as evidence of the care provided or the services given to them. The physicians will have continued access to the medical records after the consultation, especially when a patient initiates a claim or complaint. The owner or the operator of the virtual clinic having the custodian of the medical record of the patient should maintain the same in proper order.
 
For instance, BRYAN Health under the telemedicine meets the demand for virtual care and is an award-winning health system in Nebraska; they achieved their strategic growth by developing a virtual care service line with Zipnosis, a platform which allows BRYAN telemedicine to leverage internal clinical expertise and offering care to the patients.
 
Conclusion:
Virtual Clinics are a new upcoming reality to deliver healthcare. If India is thinking to evolve in the concept of a virtual clinic to provide the medical service, it is necessary to consider the medical-legal issues that can emerge. It is necessary to consider whether any special licensing requirements may apply, or the standards and guidelines concerning other medical technologies including privacy, security, consent and online prescribing are applicable.
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New Medical Technologies in India

By: admin Medical Negligence 01 Nov 2019

Nowadays, it is not surprising to see doctors using iPad to note and store the medical records of the patients. The rapid transformation of medical technology and the availability of technology for diagnostic and therapeutic equipment together with changing pattern for the practice of doctors have revolutionized the way of health care being delivered. The technology shift has cast itself by bringing a digital transformation in the interaction of patients and doctors.

The convergence of technology in healthcare has provided a huge opportunity to improve the experience of the patient and operate more efficiently. Health care technology solutions are able to improve and modernize medical care by reducing cost and avoid inefficiency.

Telemedicine, Hospital Information System (HIS), electronic records and web-based services have expanded the IT infrastructure in health care organizations of India.

Rajiv Gandhi Cancer Institute and Research Centre provides the diagnostic of high quality and take multi-disciplinary care of cancer patients. Today many of the health care institutes are at the forefront to enable the initiative of health care technology. Introduction of HIS, picture archival and communication system (PACS) and electronic health record system (EHR) has led to a rapid increase in the volume of data.

The data containing medical records of patient needs to be highly available rather than its remote accessibility with archival solutions. In the medical industry, it is very difficult to maintain the patient record, to meet the capacity demand of data-intensive medical images and records. To enhance the storage platform for fulfilling the requirement, technology helps a lot.

Revolution of Digital health Technology in India:

The statistics say that around 76% of health care professionals in India use Digital Health Technology in their practice.

Digital Health Technology is a pivotal pillar to deliver value-based care across the health care continuum in India. The technology evolved to lower the barriers between hospital and patient and to enhance the satisfaction with tools like telehealth and adaptive intelligence solutions. It was reported that about two-thirds of Indians feel comfortable about seeking medical advice from doctors through an application available on their phone. It suggests a high openness to adopt telehealth and unlock its benefits.

But the benefits of digital health technology or mobile health apps are not that popular in rural areas and also in the cities. Also, the implementation of technology is cost-effective and it is a compelling method to connect clinics in the cities and rural regions. Even though we are facing health care challenges, we are evolving the innovative solutions to help address the formidable challenges.

Recently evolved medical technologies in India include the smart inhalers, wireless brain sensors, robotic surgery, artificial organ, etc.

Smart inhaler: It is a small device called Bluetooth-enabled smart inhaler for asthma patients, which records the time and date of each dose and check whether the dose was correctly administered. The data is sent to the smart-phones of the patient to keep track and control on their condition.

Tele-health: Telehealth is a quickly developing technology that allows the patient to receive medical care through electronic devices instead of waiting for face-to-face appointments with the doctor. Highly personalized mobile apps are developed where patients can speak virtually with physicians and medical professionals to receive instant diagnosis and advice.

Precision Medicine: Advancement in Medical technology becomes more and more personalized to the patients. Precision medicine allows the physician to select therapies and medicine to treat a disease like cancer, which are based on the genetics of an individual. These personalized medicines are more effective than others as it attacks the tumour based on the genes and proteins of the patient, which helps to destroy the cause of disease.

Artificial Organs: It was revolutionary to regenerate skin cells for skin draughts of the victims suffering from burn marks. A scientist with the help of advanced technology has created blood vessels, synthetic ovaries and pancreas. The artificial organs then grow within the body of the patient to replace the faulty one.  The ability to supply artificial organ accepted by the human body is revolutionary, saving the lives of many patients.

Wireless Brain Sensor: It is a medical device that will aid doctors in measuring the temperature and pressure within the brain which reduces the need for additional surgeries. Medical technology has developed an electronic device that can be placed in the brain and dissolve when it is no longer needed.

3D printing: 3D printing is again the unique technology where these printers can be used to create implants and can be used during surgery. 3-D printed prosthetics contains the digital functionalities that match the individual’s measurements down to the millimetre. It can be used to print pills that contain multiple drugs which will help patients to monitor multiple medications.

Robotic Surgery: It is used in minimally invasive procedures and helps to aid precision. With the help of robotic surgery, surgeons can perform the complex procedures that are highly difficult to conduct. Advancement in technology can allow surgeons to view additional information which is vital during surgery. The invention raises the concern that it will replace the human surgeons, but it will only be used to assist and enhance surgeons in the future.

Virtual Reality Device: It is a sophisticated tool used to gain the experience they need while rehearsing procedures and providing a virtual understanding of the connection of human anatomy. It acts as a great aid for patients helping them with diagnosis, plans of treatment and procedures they may be going through.

Artificial Intelligence: Artificial Intelligence can be defined as the capability of devices to learn on their own without an explicit program. It is used in medical education with the potential to reduce the count of actual dissertation and help in the study of a human body.

CRISPR: Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) is the most advanced technology in editing the gene of a human. By harnessing the natural mechanism of the immune system of bacterium cells for invading viruses which will help to cut down the infected DNA strands. The cutting of DNA has the potential power to transform the way of treating a disease. With the modification of gene, the major threats of health like cancer and HIV could be potentially overcome in future.

Conclusion:

A sound regulatory framework is essential for the growth of medical technology. The government of India is in the process of developing a separate legal framework designed to ensure the quality, safety and performance of the medical devices. The framework will take into consideration certain international standards like the Global Harmonization Task Force (GHTF). However, for the safety and quality in medical devices, appropriate regulation and quality control processes will be pre-requisite for innovation to sustain.

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Legal and Regulatory Regime: Medical Technology

By: Medical Negligence 04 Oct 2019

As technology is changing rapidly, it opens the new regime within the domain of health care. Advancement in medical technology such as personal medical devices, open-source hardware and mobile phone apps are creating opportunities to improvise the medical industry.  In order to regulate the new challenges, it is necessary to balance the need for regulation along with flexibility and efficiency in the use of technology.  With the comparison of new health technology the designs, standards and regulations evolve slowly and therefore some difficulties can be faced while applying the standards to these regulations. For instance, the current regulations may not be suitable for upcoming medical technology. The standards may not be that flexible while evaluating the usability of other upcoming medical technology. Regulation for medical technology in India is ambiguous, complex and opaque. There are certain issues pertaining to regulation on medical technology. The medical technology industry has no separate legal status. Earlier, it was regulated by the Drug Controller General of India (DCGI) under the Central Drugs Standard Control Organization (CDSCO). It was found that regulation covers few medical devices under the ambit of Drugs and Cosmetic Act 1940 with subsequent amendments. But it was necessary to distinguish medical devices from pharmaceutical products.

Absence of Specific regulation and coverage under the Drugs and Cosmetic Act has resulted in a lack of transparency and clarity about the regulations. These industry face problems pertaining to multiple levels of government authority involved in enforcing the guidelines and inconsistent interpretation of the regulatory guidelines by authorities. It resulted in a prolonged and cumbersome regulatory pathway for new and existing products.

India’s Ministry of Health and Family Welfare released the Medical Device Rules, 2017 which came into force from 2018. It contains the regulations applicable to medical devices and in-vitro diagnostic medical devices. The regulation states that all medical devices will be placed into four classes based on the use of device and the risk of using the device. The government has been selective in the regulation of medical devices as until the device has been notified under Drug Cosmetic Act and Medical Device Rules it will not be regulated. The government has overhauled the regulatory framework and has brought it at par with international norms with the concept of ‘risk-based regulation’.

Under the applicable regulatory framework of medical devices, the function of manufacture, import, sale and distribution of medical devices require licenses or permissions from the Central Drug Licensing Authority and State Drug Licensing Authority.

Manufacturing a medical device requires a separate license for each medical device which is notified. Also, for importing the medical device in India it is necessary to satisfy a few additional legal requirements. The import of all medical devices is governed under the Export and Import Policy.

To understand how the regulatory framework around medical technology is evolving, the comparison of Indian regime with other developed countries can be followed.

In recent years, due to the rapid advancement in scientific discovery and technology developments in the UK, it helps the patient to manage and track their health conditions on the go. Also, the growing number of health technologies available can be adapted to support personal care in terms of electronic devices.

For instance, three-dimensional printers are devices that create three-dimensional objects based on electronic data where printers have opened up the possibility to produce custom made medical devices as and when needed. These types of advances continue to provide solutions to health care problems that seem to be impossible to solve and they generate their own considerations about the procedure to see how these technologies fit into existing regulatory framework.

But the medical technologies do not always fit into the specified standards because they take a step ahead from what it is currently accepted as practised. There are possibilities that innovation may be hurt by the current regulatory system. However, sometimes the existing standards may not be applied or in use and after development in modern technology they are unable to apply. The steps followed for the development and testing the medical device was created with a traditional manufacturing process, at a certain point, the design would be freeze and considered as complete. Repeated change in standards and its requirements may be cumbersome for evolving medical technology.

Even though there has been progressing towards using explanatory method to investigate the context of use, standards are lacking in their treatment. The experience of user relates a context that the important factor in determining how people will accept the technology and interact with it.

There is an opportunity for standards to support consideration of a broader range of context.

Also, there are many issues in the certification of health-related apps. Regulation is required and although guidance on technologies may exist, it may not be clear whether such standards can be covered under regulations.

For medical technology, the standards and regulations are needed to ensure safety for protecting the public and guarantee that products are fit for purpose, the current approach towards regulation is not only feasible but difficult to enforce.

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Intellectual Property in Medicine

By: Medical Negligence 04 Oct 2019

Introduction: Access to medicine is a tool that plays a significant role in the lives of people. It has been a life-saving instrument which helps in eliminating diseases by its consumption, application or any other use as prescribed by doctors. World Health Organization with its research has reached to the conclusion estimating that one-third of the world’s population has no access to proper medicines, though the figure has changed from 2.4 billion to 4.3 billion between the year 1975 and 1999. India has been one of the countries where access to medicine has been a real-time issue for the government. As per statistics, 39 % of Indian people have issues relating to access to medicine. Income level of an individual also affects the life of the person regarding his right of access to medicine. Access treatment has also become a problematic thing as the medicine used in such treatment have become unaffordable or ineffective due to resistance or not sufficiently adapted to specific local conditions or constraints. Out of 1223 new medicines approved in the year 1975 and 1997, approximately one percent drugs specifically treat tropical diseases. India’s share coupled with Africa is just 2.3 % of the global market as compared to the developed nations.

Government’s Investment in Health Care

Though the government in its reports mention a higher amount of expenditure on healthcare in the country, globally the government sector is investing less as compared to the private sector. Government investment in percent to GDP (Gross Domestic Product) had a steady rise until the year 1990-1991 and it has remained to stagnate since then. The per capita expenditure is also same or stagnate since 2000-01. Cost of purchase of medicine is sixty- seventy percent of the treatment making it impossible for poor to pay the cost. At the same time, medicine accounted more for the countries which had a very low or low-income population as compare to high net income population. There is a long trend in communicable and non-communicable diseases with changes in lifestyles.

Reforms in patents

A dream of healthy India is becoming a reality but at the cost of time. There is a part of India that has adopted artificial intelligence, smart technologies for surgeries and operations and there's a part of India who is oblivious to advancement happening in the country. For a developing state, it is more important to make medicines which are more affordable so every person can afford to buy it. From the past two decades, complying with growth, India has made a significant contribution to healthcare by making medicines more accessible to the public. India as a developing nation needs new innovation in drugs, development in the therapeutic domain and building healthcare facilities. The revised version implemented by India regarding the Patent Law was made in order to comply with Trade-Related Aspects of Intellectual Property Rights. India before enacting the amended act of 2005 was at the following stage:

  1. Indian pharmaceutical industries grew as one of the fastest-growing industry in the production of generic medicines.
  2. Indian market encouraged the domestic players for manufacturing the drugs.
  3. The Act granted the patent on the process as against the global rule of registering the product alone or singly under the Patent.
  4. There was a wider distribution of generic product or medicines at a generally reasonable price making it more affordable for people to buy.
  5. There was no big peep from global market players in-country or global big players showed no interest in the Indian market.

After the amendment act 2005 the position of India was:

  1. A rule was introduced to the act stating the duplication of any medicine before 1995 will be illegal.
  2. Global players in the pharmaceutical industry showed a gradual interest in Indian markets for their expansion.

A favourable policy relating to Intellectual Property is required for attracting the investment in India by foreign players, patent registration system should be made more smooth eventually catalyzing the research and development in the healthcare sector.

Make in India has brought a lot of changes in patent law encouraging the patent protection for innovation. As per the report provided by the patent registration office in India, it has been stated that the pharmaceutical industry is the major contributor in the patent registration, registering more than 20,000 patent since 2015. However taking them into consideration it's been said that patenting the product will eventually make the price of the product higher, making it unaffordable for people to buy. But Supreme Court has been the custodial of the rights of common man, as the needs of the common man have never been compromised. Such claim has been proved not so long ago but in 2013 in Novartis case of Glivec. In 2013, the Supreme Court denied the plea for patenting the cancer drug Glivec by Novartis.
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