Telemedicine Practice Guidelines were prepared by Board of Governors (in suppression of Medical Council of India) in partnership with Neeti Aayog and approved by Ministry of Health and Family welfare, Govt of India vide Letter No. V.11012/07/2020-MEP dated 25.03.2020 and released under notification dated the 25th March, 2020 No. MCI-211(2)/2019(Ethics)/201855 enable Registered Medical Practitioners to Provide Healthcare Using Telemedicine.
However Indian Medical Association has categorically declared that there is lack of clarity on medicolegal implecations, and procedures prescribed by statuory bodies do not necessarily absolve the doctor from his liabilties.
IMA therefore has identified only two areas for use of telemedicine
a. triaging patients and identifying patients who need to go over to hospitals
b. advising regular patients like DM, HT due for review for continued treatment.
This has created an impasse which needs to be sorted out by understanding issues in telemedicine.
In its guidelines WHO has stated that Digital health has the potential to help address problems such as distance and access, but still shares many of the underlying challenges faced by health system interventions in general, including poor management, insufficient training, infrastructural limitations, and poor access to equipment and supplies. These considerations need to be addressed in addition to the specific implementation requirements introduced by digital health.
Many health workers, particularly in rural and remote areas, experience logistical challenges when using digital health technologies, including poor network connectivity and access to electricity to charge their mobile phones. In some instances, poor connectivity also results in client dissatisfaction because it creates delays in receiving health services. Although the introduction of digital health interventions into existing healthcare systems may be important, this requires many changes and may be difficult to achieve
First and foremost is the legal hurdle. High Court in celebrated Martin D'souza case at paragraph 54 of the judgement said Precautions which Doctor/Hospitals/Nursing Homes should take : (b) No prescription should ordinarily be given without actual examination. The tendency to give prescription over the telephone, except in an acute emergency, should be avoided. Whether there was acute emergency at the time of giving prescription will be an issue, even during epidemic, and by virtue of this judgment doctor will be at disadvantage if patients makes allegation of negligence. There is talk of Supreme Court supporting Telemedicine, but there is no precedent, nor there is clear guideline from Supreme Court.
Recently the Bombay High Court held that prescription without diagnosis, resulting in death, amounts to criminal negligence. In Deepa Sanjeev Pawaskar & Anr versus the State of Maharashtra, the Court dismissed the anticipatory bail plea of two doctors involved in such a case as The medicines were administered on telephonic instructions without even enquiring about the symptoms or nature of the pain suffered by the patient. On 17th September 2018 The Indian Medical Association has sought clear guidelines from the Medical Council of India on telemedicine. Telemedicine Practice Guidelines which have been notified by Board of Governers on 25th March 2020 appear to have been issued hurriedly as they have several flaws which may be challenged in the court.
However Indian Medical Association has categorically declared that there is lack of clarity on medicolegal implecations, and procedures prescribed by statuory bodies do not necessarily absolve the doctor from his liabilties.
IMA therefore has identified only two areas for use of telemedicine
a. triaging patients and identifying patients who need to go over to hospitals
b. advising regular patients like DM, HT due for review for continued treatment.
This has created an impasse which needs to be sorted out by understanding issues in telemedicine.
In its guidelines WHO has stated that Digital health has the potential to help address problems such as distance and access, but still shares many of the underlying challenges faced by health system interventions in general, including poor management, insufficient training, infrastructural limitations, and poor access to equipment and supplies. These considerations need to be addressed in addition to the specific implementation requirements introduced by digital health.
Many health workers, particularly in rural and remote areas, experience logistical challenges when using digital health technologies, including poor network connectivity and access to electricity to charge their mobile phones. In some instances, poor connectivity also results in client dissatisfaction because it creates delays in receiving health services. Although the introduction of digital health interventions into existing healthcare systems may be important, this requires many changes and may be difficult to achieve
However, individuals who are dealing with health conditions that are often stigmatised or very personal (e.g. HIV, family planning and abortion care) worry that their confidential health information will be disclosed or their identity traced due to their participation in targeted communication programmes. Some individuals using telemedicine services prefer face-to-face contact. Health workers on the other hand may be concerned about having to work beyond their clinical capacity and about potential issues of clinical liability.
WHO therefore recommends client-to-provider telemedicine under the condition that it complements, rather than replaces, face-to-face delivery of health services; and in settings where patient safety, privacy, traceability, accountability and security can be monitored.
In this context, monitoring includes the establishment standard operating procedures that describe protocols for ensuring patient consent, data protection and storage, and verifying health worker licenses and credentials.
In view of above, it is necessary to create a mechanism which will help the doctor to take consent from the patient and then render required services to benefit the patient while getting remunerated for the same. Let us look at this from Indian context.
Recently the Bombay High Court held that prescription without diagnosis, resulting in death, amounts to criminal negligence. In Deepa Sanjeev Pawaskar & Anr versus the State of Maharashtra, the Court dismissed the anticipatory bail plea of two doctors involved in such a case as The medicines were administered on telephonic instructions without even enquiring about the symptoms or nature of the pain suffered by the patient. On 17th September 2018 The Indian Medical Association has sought clear guidelines from the Medical Council of India on telemedicine. Telemedicine Practice Guidelines which have been notified by Board of Governers on 25th March 2020 appear to have been issued hurriedly as they have several flaws which may be challenged in the court.
The guidelines saty that telemedicine has some risks, drawbacks and limitations, which can be mitigated through appropriate training, enforcement of standards, protocols and guidelines. however these issues need to be spelled out clearly so that they can be referred to in case of dispute between doctor and patient at a later date.
The guidelines are in the form of priviledged document accssible to RMP. It should be accessible to the patient also so that they understand various issues.
Guidelines prescribe that RMP shall maintain all patient records including case history, investigation reports, images, etc. as appropriate. Many times reports, images are with patient and they can not be accessed in most common form of teleconsultation which is telephonic coversation.
The professional judgment of a Registered Medical Practitioner should be the guiding principle for all telemedicine consultations, as per the TPG. However the onus of decision can not be entirely on the RMP. There is nothing about contributory negligence by patients of not disclosing all material facts to the doctor, and for this informed consent is required to be taken. Unfortunately, guidelines say that when patient initiates teleconsultation consent is implied. How can the consent be implied when patient does not have knowledge about issues and limitation in teleconsultation?
TPG state that if a physical examination is critical information for consultation, RMP should not proceed until a physical examination can be arranged through an in-person consult. This can become an issue in case of dispute : Physician says examination was not required, court feels it was required hence negligent. RMP can potentially make an error of judgement just by asking information, and may fail to take a correct decision regarding need of calling patient to clinic. Patient on the other hand MUST undertake to attend the clinic if RMP so advises and also visit the clinic for followup, and also to get investigations done as advised by the RMP during the consultation process.
The Information transmitted may not be sufficient to allow for appropriate medical decision by the physician due to technological problem such as
a. poor quality of voice,
b. poor resolution of images,
c. deviation in color of images,
d. lack of understanding on both sides because both RMP and patient are not face to face.
Hence the patient should understand that there will be several limitations on advice being given by the RMP due to the very nature of this unusual approach to try and help the patient. The patient needs to appreciate that there is no negligece, if there is any deficiency of service due to remote consultation. The physician has done so in utmost Good Faith to help the patient; as due to various reasons, patient cannot meet / seek conventional consultation / medical help.
The doctor may choose to use methods other than a verbal discussion or a written document, such as videos, interactive computer modules, audio files or other methods to help the patient understand the information better. Video, audio, and/or digital photo may be recorded during the telemedicine consultation visit and permition should be soughgt by RMP to record the conversation as well as images during the consultation process.
The patient should be aware that the provider has taken reasonable and appropriate efforts to eliminate any confidentiality risks associated with the telemedicine consultation. Dissemination of any patient-identifiable images or information from the telemedicine interaction to researchers or other entities shall not occur without patients consent, unless authorized under existing confidentiality laws.
As a condition to receiving the online consult service, patient should giving consent without any pressure or force, and while not being under influence of any drugs or alcohol am agreeing to various limitation in telemedicine and give consent of own free will. The patient should assume risk of the limitations set forth and further understand that no warranty or guarantee can been made to the patient concerning any particular result related to any condition or diagnosis.
In view of above www.takemycare.in provides an eConsent mechanism which may be used for taking consent from the patient before starting teleconsultation process, whether the request was initiated by the patient or by the doctor. Better to be safe than sorry..!!
No comments:
Post a Comment