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Virtual Clinic
  • By: admin
  • Date: 01 Nov 2019
  • Medical Negligence
  • Comments:
  • Views:48
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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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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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Artificial Intelligence in healthcare

By: Medical Negligence 02 Oct 2019

Healthcare in India is growing and complex phenomena due to the increase in population with the same set of healthcare centres eventually resulting in inefficient service towards people suffering from various diseases. The problem still exists as the health care system in India has a complex structure. This health care industry structure is divided into multiple layers. Historically, the Indian sector was governed mainly by a government agency but due to an increase in the private sector, it has resulted in a growing or expansive presence of the private sector in this field. Even though the rules of this sector are governed under the primary health care sector, the presence of private sector is majorly in the secondary and tertiary sector. Technological development in a country with a population of 1.3 billion has its own significance in developing the health care system in the country. Artificial intelligence is the next big innovative and non-invasive method introduced in very own form in the country by many start-up firms. Introduction of technology in medical science has been a way by which there are higher chances of eliminating human errors.

What is Artificial Intelligence?

It is basically called as machine intelligence in terms of computer science. It a contrast version of natural intelligence depicted by the human in real sense.

Artificial Intelligence in Healthcare

Increase of technological use in the healthcare system has been a virtue or kind of a blessing for doctors or medical caregivers. Use of medical devices in hospitals and health care centres, various mobile applications and wearable devices helps to maintain the health condition of the customers who buy it and also helps the doctors for early detection of any health issues. Many hospitals these days use technologies. Introduction of artificial intelligence is expected to reduce this manual effort making it probably negligible. For Example:
  1. Manipal Hospital, one of the leading hospitals in India uses the artificial intelligence technique to get the early diagnosis of diseases they intend to cure. Manipal hospital is using IBM’s Watson for Oncology a cognitive computing platform for helping physicians discovering new ways for cancer protection and care options.
  2. Columbia Asia Hospital uses an artificial intelligence technique for the purpose of early diagnosis of heart diseases or anything related to cardiovascular.
Most of the pioneering players in India are introducing artificial intelligence techniques to enhance the productivity of the health care options by medical sciences. Microsoft has been a leading player in the techno-medical environment by use of cloud computing and artificial intelligence unit known as Healthcare Next. Some of the initiative by Microsoft India that has its roots in eliminated the eye diseases, Microsoft by working parallel with State Government has launched a scheme known as Microsoft Intelligence Network for Eyecare. The state of Telangana has launched a scheme called as Rashtriya BalSwasthya Karyakram helping children to eliminate the diseases regarding eye. 

Policy and Regulatory Framework

As any new technology is to be introduced in India, there is a framework that has been build in which such technology needs to comply with certain parameters and provisions as per the law for smooth implementation.

  1. Indian Medical Council Act, 1956 and Indian Medical Council (professional, conduct, ethics and etiquette) Regulation, 2002
  2. Electronic Health Records: Government has introduced the electronic health records, 2016 as a standardized method for regulating the data ownership and privacy standards for collecting health data from patients, this regulatory code also includes the data collected from the medical establishment, medical devices and self-care devices and systems
Data Ownership: - Even though the data is stored by the medical establishment relating to the patient, the customer has the full right over such information.
Data Accesses: - Patients as the rightful owner should have complete access over the data as they are one who can permit its disclosure; no person should disclose the data without prior permission of the concerned person.
Changes to data: - Once the data entered by the person should not be allowed for changes, further changes regarding the data should be accompanied by an audit trail.
Disclosure of Health Information: - Any information related to health can be disseminated only if the identifiers were removed.
Access to health records by Courts: - Any health records demanded by the court should be presented in as it is stated, such information can be disclosed without prior approval and with the procedure established by law.
Responsibility of Health providers: - The responsibility of a health provider is to maintain the data and take its whole responsibility. Such a provider should not submit the data or disclose it without prior permission of the concerned person or by the procedure of the law.
Encryption of the data: - Electronic health records should compulsorily be encrypted with a minimum of bit encryption keys.
Identification: - Patients aadhar card should be used as an identifier and in the absence of aadhar card any two government IDs can be used.

Example of effects on Patient

In India, 50 % of the women die within half a decade due to a diagnosis of breast cancer, as the traditional cure pattern in medical science is not the upright solution for the disease. Usage of Artificial Intelligence can help in early detection of cancer. AI-based cancer screening test using machine intelligence over thermographic images have given a low cost, easy to operate and portable solution for detecting cancer, thus improving the health condition resulting in survival. Also, the screening test is non-contact, painless and free of radiations.

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Guidelines to protect doctors from frivolous and unjust prosecution

By: admin Medical Negligence 26 Jul 2019

The number of cases filed for medical negligence is increasing day by day. However, a lot of these cases are coming to light as frivolous and baseless. 
 
Frivolous cases have severe repercussions on doctors, affecting their business image as well as career.
 
Patients should realize that not every doctor, who they disagree with, is a criminal. The Medi-care system is so open to fraud because there is so little oversight of the actual facts and cases.
 
The Judges have understood this pattern and are continuously pushing back on such unjust prosecution. 
 
The Supreme court has held that:-
  1. A medical negligence complaint should not be entertained without prima facie evidence submitted to the court.
  2. Along with an expert opinion to support a claim of negligence.
  3. A doctor may not be arrested unless his arrest is necessary to further the investigation or if the investigating officer is of the opinion that the doctor would not make himself available unless he is operated.
 
Doctors should fight these frivolous claims. To aid this, the Indian Medical Council has approved a list of guidelines to protect doctors from unjust and frivolous claims. The Central Government has to approve and pass the notification. 
 
The guidelines are to be observed by the prosecuting agencies and they are implemented to protect doctors from frivolous and unjust prosecution:
 
  1. Before making the arrest, the prosecuting agency shall refer the complaint to the Chief Medical Officer. He shall place it before the District Medical Board for its recommendations based on the merits of the case.
  2. The District Medical Board shall examine the allegations of the medical negligence (within two weeks) and send the findings back to the prosecuting agency 
  3. The Board conducting the examination shall ensure that a doctor qualified in that branch of science, on which the allegation is based, was a part of that Board.
  4. In case the prosecuting agency is not satisfied by the findings of the District Medical Board, after stating the reasons for the same, the agency shall refer the matter to the Divisional Medical Board within three weeks of the recommendations issued by the District Medical Board.
  5. The Divisional Medical Board shall give reasons for either accepting or rejecting the recommendations of the District Medical Board. The decision of the Board shall be conveyed to the prosecuting agency withing four weeks.
  6. In case the prosecuting agency is dissatisfied with the recommendations of the Divisional Medical Board, after stating the reason for the same, the agency shall refer the matter to the State Medical  Board within four weeks of the recommendations issued by the Divisional Medical Board.
  7. The State Medical Board shall give reasons for either accepting or rejecting the recommendations of the Divisional Medical Board. The decision of the Board shall be conveyed to the prosecuting agency withing five weeks.
  8. The prosecuting agency, on the basis of the recommendations of the District/Divisional/State Medical Board, should further proceed in accordance with the law. 
  9. In case of an arrest of a medical practitioner employed by the state or central government, the controlling officer of the medical practitioner shall be informed by the prosecuting agency.
  10. In case of an arrest of a medical practitioner, engaged in private practice, the concerned State Medical Council is to be informed by the prosecuting agency.
 
It is a dire need of the hour to implement these guidelines promptly.
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Unjust Compensation - A Doctors Perspective

By: admin Medical Negligence 26 Jul 2019

Nowadays, the basic knowledge of how the judicial forums deal with medical negligence cases is necessary for doctors due to the increase in frivolous and unjust matters. The knowledge of how the compensation is calculated and adjudicated in the judicial courts of India will assist doctors to get indemnity insurance associated with it, without any worry about the high-cost litigation involved with medical negligence cases.

The Indian Judiciary put some light on the premium of the value of human life and their suffering.  They aim to maintain a careful balance between the autonomy of the doctor and the rights of the patient to be dealt with fairly. The balance is maintained to give proper treatment to patients and to identify the delinquency in cases if any. 

The compensation shall be awarded after taking into consideration the following pointers which may affect the doctors and their profession:

  1. The paying capability or the earning capacity of a medical practitioner.
  2. Immeasurable delays in court may affect the reputation of the medical practitioner. 

The hospital as an organization is not run by the doctors but by the administrators. Hospital administrators are primarily concerned about the revenue that generates by imposing targets on the doctors. In such cases, if medical negligence arises, then who will be liable for the compensation. Many times, it is seen that both the hospital and doctors are held responsible for paying compensation. Whereas in some cases, the court reduced the amount of compensation payable by the individual doctors as compared to the hospitals.

The purview of the Indian legal system is that the treatment provided by a doctor can be inexact and vary with the rapid advancement and substantial responsibility as the service provider.  Therefore, the calculation of compensation is not precise or accurate. There is an immediate need to introduce broad guidelines and assessment parameters to support the health system. The compensation awarded requirements to be just, prudent and reasonable. The deficiencies, such as substantial cost of litigation, delayed litigation, as well as dependence on judicial restraint, will not provide effective justice to victims and also harm the doctors and hospitals.

In the case of a frivolous matter, the doctor should be compensated for the loss of his time, money and reputation. The Indian government needs to act and invest the guidelines in health care before it is too late.
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Misdiagnosis: A Medical Negligence?

By: admin Medical Negligence 26 Jul 2019

Diagnosis is an essential task performed by physicians. To treat a patient of an illness, the first step of treatment is his diagnosis.  
 
A diagnosis is the identification of a condition in the form of a disease or disorder. It is an examination conducted on the body of the patient to determine probable causes of his condition. 
 
Misdiagnosis is the primary reason for filing a medical negligence claim. The World Health Organization (WHO) recently prioritized patient safety areas and included diagnostic errors as a high-priority problem.
 
A misdiagnosis may relate to a wrong diagnosis, delayed diagnosis or failure of diagnosis. 
 
When a doctor's diagnosis leads to an error in treating the illness of the patient, which results in worsening the situation of the patient, shall amount to medical negligence. However, not all wrong/delayed diagnosis shall have a basis for a medical negligence claim.
 
A patient filing a case for medical negligence based on the misdiagnosis of the doctor has to establish the following:
 
  1. Doctor-patient relationship
  2. Failure of providing standard care in conducting a diagnosis on the patient. (Review to be based on expert opinion)
  3. Misdiagnosis causing an injury
  4. The patient must submit proof that the doctor did not correctly diagnose him and that a competent doctor a doctor of the similar speciality would have diagnosed correctly.
 
Generally, in case of a death, it is challenging to prove misdiagnosis in India since there is no proper mechanism to report it except under medical negligence. 
 
Also, to prove misdiagnosis, one would have to request for an autopsy, which is an expensive affair, and not everyone can afford it. Even if the family of the patient inclines towards requesting an autopsy, it is difficult for a layman who does not understand medical terms, to take a wise call. 
 
There are several reasons due to which misdiagnosis takes place. It is for the court to decide on the merits of each case individually whether it would be regarded as a defence available to the doctor, or would the doctor be held liable for medical negligence for misdiagnosis.
 
Different reasons/causes of misdiagnosis:
 
  1. The diagnosis was based on erroneous lab results conducted by a non-interested third party
  2. A piece of flawed equipment is used for conducting diagnosis
  3. A technician who wrongly administers the test 
  4. A secondary who misreads the scan
  5. Results of tests swapped between patients
  6. The limited-time associated with each patient 
 
For the above instances, if the concerned or diagnosing doctor is not liable, some other party will be liable. For example- the doctor is not responsible in case of 'results of tests being swapped' since it is the hospital staff who is involved in giving the doctors the test results.
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Exemption of doctors operating in Emergency Rooms

By: admin Medical Negligence 26 Jul 2019

Emergency rooms are very chaotic by nature. Generally, the Doctors present in the emergency rooms diagnose the patients who are needful to seek medical care due to accidents, sudden violent act, illness or any other medical condition. Medical records may not be thoroughly reviewed due to the lack of time that a doctor of the emergency room has to assess the situation before giving treatment. Thus, in the cases of medical negligence doctors present in the emergency room may be given more breathing space than other doctors treating the patient. Treatment in an emergency room means trusting the strangers to save the life of the patient. Emergency room injuries are the sudden physical, emotional, and financial hardships for the patients and their families.

A doctor who examines the patient is the first attending physician performing medical work upon arrival of the patient at the emergency room. In an emergency room, the situation is so terrible that the tests consume a longer period of time; tests such as a CT scan or an MRI cannot be done on the basis of emergency. But emergency in the environment does not eliminate the duty of doctor’s to perform specific tests to isolate the problem. 

Errors faced at Emergency Room:

  1. Failure to get the medical history of the treating patient
  2. Due to the lack of time, it is difficult to perform an accurate physical examination
  3. To recognize the life-threatening causes of patient health
  4. To come on a conclusion about the health of a patient in a hasty manner, without considering alternative treatment or analysing the present medical condition of the patient
  5. Misdiagnosis, delay in diagnosing or treating the patient
  6. Delay in performing test which is necessary in case of emergency
  7. Laboratory errors or the dumping of patient or transfusion of the contaminated blood
  8. Failure to monitor a patient properly 
  9. Inappropriate medications or improper doses 

Injuries Caused by malpractice at Emergency Room:

It would be impossible to list the injuries resulting from malpractice in the emergency room. However, some are more commonly included:
  1. Severe cardiac attack or death from an undiagnosed heart attack
  2. Death from undiagnosed stroke or paralysis
  3. Severe damage to organs or limbs due to misdiagnosis by a doctor
  4. Infection or ill-treatment

To avoid errors, some measures can be taken into consideration:

  1. To engage the adequate number of doctors and the supporting staff in the emergency rooms.
  2. To provide with the adequate facilities 
  3. To maintain the sanitary condition 
  4. To maintain the records of the patient and to look for the tracking procedure of the patient. 
  5. Proper medication administration procedure
  6. Ethical treatment to the patient

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General Types of Medico-Legal Cases (MLC)

By: admin Medical Negligence 26 Jul 2019

Most doctors come across medico-legal cases (MLC) in their medical career. An MLC is a case of injury wherein an investigation by the law enforcing agency is necessary to get to the bottom of the cause of the injury. In other words, it is a medical case with legal implications for the doctor, where he, after the examination of the patient, thinks that some investigation by law enforcement agencies is essential. It also includes a legal case requiring medical expertise when brought by the police for examination since a doctor's knowledge may be necessary for the administration of law.
 
Instances of MLC are:
 
  1. Cases of injuries and burns that suggest the commission of an offence.
  2. Unnatural accident cases of grievous hurt or death
  3. Sexual assault
  4. Criminal abortion
  5. Unnatural unconsciousness
  6. Poisoning or intoxication
  7. Cases referred by the courts
 
The Government has issued a list of guidelines and the manner in which care has to be given to the MLC survivors:
 
  1. Initial resuscitation or first aid
  2. Required consent for examination
  3. Detailed history
  4. Medical examination
  5. Age estimation, if requested
  6. Providing the collected evidence to police
  7. Documentation
  8. Treatment of injuries
  9. Psychological counselling
 
  • The doctor should carefully examine and treat the patient, record the date, time, place, brought by whom and examination finding. The doctor should also record the dying declaration of the patient if he is on the verge of death.
  • As per section 39 of the Criminal Procedure Code, the doctor must report the MLC to police after the completion of primary lifesaving medical care. The aim is to initiate the legal proceeding at the earliest to gather maximum evidence by the police. Quick and effective action by the police also helps to avoid the destruction of evidence.
  • The law states that issues such as legal formalities, monetary constraints or infrastructural restraints of the institution should not prohibit the hospital from providing basic and emergency medical treatment.
  • Generally, all the big hospitals and teaching institutions have a detailed manual on how to deal with MLC's. However, even if these manuals are not available, MLC's pose no problem if the doctor uses proper care and caution in dealing with them.
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