The term telehealth includes a broad range of technologies and services to provide patient care and improve the healthcare delivery system as a whole. Telehealth is different from telemedicine because it refers to a broader scope of remote healthcare services than telemedicine. While telemedicine refers specifically to remote clinical services, telehealth can refer to remote non-clinical services, such as provider training, administrative meetings, and continuing medical education, in addition to clinical services. According to the World Health Organization, telehealth includes, “Surveillance, health promotion and public health functions.” Telemedicine involves the use of electronic communications and software to provide clinical services to patients without an in-person visit. Telemedicine technology is frequently used for follow-up visits, management of chronic conditions, medication management, specialist consultation and a host of other clinical services that can be provided remotely via secure video and audio connections.

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MEDICO LEGAL DOCUMENTATION MANAGEMENT & TELEMEDICINE
LEGAL ASPECTS OF TELEMEDICINE: TELEMEDICAL JURISPRUDENCE
 Telemedicine consultation(or “teleconsultation”) has beenofferedby
doctors in India since the year 2000. However, inthe absence of statutory
basis and support, it was not clear whether it was legal or not. In fact,
there have beennews reports that State Medical Councils hadbannedthe
practice of teleconsultation.
 As per Section 27 of the Medical Council of India Act, 1956, any person
who is enrolled in Indian Medical Register, can practice in any state of
India. Hence inter-state telemedicine service was legal, though it was not
formalized.
 Telemedicine services were governed by the IT Act, 2000, but there were
no clear guidelines regarding privacy, security, the confidentiality of
patient data, and misuse of electronic data records related to the
healthcare industry.
 Looking at the severity of the situation during the Covid-19 pandemic, the
Indian government had launched guidelines for telemedicine solutions on

2. March 25, 2020. Previously, telemedicine operations were governed by
several statutory guidelines in India.
 The current telemedicine guidelines in India provides a more
comprehensive framework for applications, mode of communication,
medical ethics, data privacy and confidentiality, document requirements,
fees, process, drug list, technological platformsandmore.
 The development of informationtechnology has had a dramatic impact
on society.
 Telemedicine is the transfer of medical informationand expertise via
telecommunications andcomputer technologies, tofacilitate diagnosis,
treatment andmanagement of patients.
 Telehealthincludes distance learning, medical peer review, patient
educationinitiatives, etc. The internet, cell phones ande-mail are
nowadays not a new area, and if healthcare providers want toenter this
domain, they shouldbe well acquaintedand do so withcautionas there
are medicolegal implications of telemedicine relating toregistration,
licensing, insurance, quality, privacy andconfidentiality issues, as well as
other risks associatedwithelectronic healthcare communication.
 The next important aspect is the physicianpatient relationship, the
standardof care and informedconsent. These are very intricate issues
which can be a reasonfor litigation.
 Further issues intelemedicine, telehealth, teleconsultation,
telemonitoring, teletreatment andpatient informationrecordalsoneed
to be addressed.
 Evidence suggests that telehealth provides comparable healthoutcomes
when comparedwithtraditional methods of health care delivery without
compromising the patient–physicianrelationship, andit alsohas been
shown toenhance patient satisfactionandimprove patient engagement.
 Obstetrician–gynecologistsandother physicians whopractice telehealth
shouldmake certainthat they have the necessary hardware, software,
and a reliable, secureinternet connectiontoensure quality care and
patient safety.

3.  To implement atelehealthprogrameffectively, participating
sites must undergoresource assessments toevaluate equipment
readiness.
 Since telemedicine uses technology todiagnose andmonitor patients
there are chances of medico-legal issues if they are not managed
properly.
 The professional judgment of a RegisteredMedical Practitioner shouldbe
the guiding principle for all telemedicine consultations.
 An RMP is well positionedtodecide whether atechnology-based
consultationis sufficient or anin-personreviewis needed. Practitioner
shall exercise proper discretionandnot compromise on the quality of
care.
Seven elements need to be considered before beginning any telemedicine
consultation.
1 Context
2 Identificationof RMP and Patient
3 Mode of Communication
4 Consent
5 Type of Consultation
6 Patient Evaluation
7 Patient management
First of all let us see detailed definitions intelemedicine:
1. TELEMEDICINE

4. ‘The delivery of healthcare services, where distance is acritical factor, by all
healthcare professionals using informationandcommunicationtechnologies
for the exchange of validinformationfor diagnosis, treatment andpreventionof
disease andinjuries, researchandevaluation, and for the continuing education
of healthcare providers, all in the interests of advancing the healthof
individuals and their communities.’
2. TELEHEALTH
‘The delivery andfacilitationof healthand health-relatedservicesincluding
medical care, provider and patient education, healthinformationservices, and
self-care viatelecommunications anddigital communicationtechnologies.’
3. REGISTERED MEDICAL PRACTITIONER
‘A RegisteredMedical Practitioner [RMP]is apersonwho is enrolledinthe State
Medical Register or the IndianMedical Register under the IndianMedical
Council Act 1956.’ [IMC Act, 1956]
THE FOLLOWING MEASURES SHOULD BETAKEN TO AVOID MEDICO-LEGAL
ISSUES:
a) Legal and Regulatory affairs
 Obstetrician–gynecologistsandother physicians whoprovide tele-health
shouldmeet the safety measures before providing tele-health. This
includes federal, state, andlocal regulatory laws and license
requirements.1
 Licensing is state specific for all physicians whoprovide telehealth, thus
making it difficult for physicians toprovide guidance across states.1
 Telemedicine parity refers tothe equivalent healthinsurance
reimbursement for similar in-person andtelehealthservices. Becausenot
all states have parity laws, obstetrician–gynecologists considering
offering telehealthservicesshouldbe aware of relevant state policies.
b) Identificationof the patient and the medical practitioner
 The medical practitioner giving teleconsultationshouldconfirmthe name,
age, address, email address, phone number and registeredID of the
patient.2

5.  The practitioner shouldbeginconsultationby providing name and
qualifications.2
 The practitioner shouldbe credentialedat the facility where the patientis
located.1
 It is important for the practitioner to display the registrationnumber
allottedby the by the State Medical Council/MCI, onprescriptions,
website, electronic communicationandreceipts etc. giventothe
patients.2
c) Patient Consent
Patient consent is necessary for any telemedicine consultation. The
consent can be Impliedor explicit depending onthe following situations:
If, the patient initiates the telemedicine consultation, then the consent is
implied2
An Explicit patient consent is needed if: A Health worker, RMP or a
Caregiver initiates aTelemedicine consultation.
An Explicit consent can be recorded in any form. Patient can send an
email, text or audio/video message. Patient can state his/her intent on
phone/video to the RMP (e.g. “Yes, I consent to avail consultation via
telemedicine” or any such communication in simple words). The RMP
must recordthis in his patient records.
d) Integrationof Electronic Medical Records
 Electronic medical records (EMRs) canbe customizedonthe basis of the
individual site requirements. Phones andmobile apps can be pairedwith
EMRs toinsert and recover patient information.1
 If more than one type of EMR software is usedbetweenorganizations, and
the connecting software is not possible, other means of secure
standardizationdataexchange that satisfy security requirements should
be incorporatedtoensure continuity of patient care.1
 If EMR integrationis not possible physicianandstaff members shouldalso
communicate by secure methods like fax or email.1
e) MAINTAIN DIGITAL TRAIL/DOCUMENTATION OF CONSULTATION
 It is incumbent on RMP to maintain the following records/ documents for
the period as prescribed from time to time: Log or record of Telemedicine

6. interaction (e.g. Phone logs, email records, chat/ text record, video
interactionlogs etc.).
 Patient records, reports, documents, images, diagnostics, dataetc.
(Digital or non-Digital), utilizedinthe telemedicineconsultationshould
be retained by the RMP.
 Specifically, incase a prescriptionis sharedwiththe patient, the RMP is
requiredtomaintainthe prescriptionrecords as requiredfor in-person
consultations.
f) Treatment and prescriptions
 If the RMP has prescribed medicines, RMP shall issue a prescription
as per the Indian Medical Council (Professional Conduct, Etiquette
and Ethics) Regulations and shall not contravene the provisions of
the Drugs and Cosmetics Act andRules.
 RMP shall provide photo, scan, digital copy of a signed prescription
or e-Prescriptiontothe patient viaemail or any messaging platform
 In case the RMP is transmitting the prescription directly to a
pharmacy, he/ she must ensure explicit consent of the patient that
entitles him/her to get the medicines dispensed from any pharmacy
of his/her choice.
 They should follow the same treatment guidelines of in-patient
visits andshouldobey the available laws and regulations.1
 The standardformat of prescriptionshouldbe followed.
 A picture of the signed prescription or E-prescription should be kept
for records.2
g) Billing andPayment - Fee for Telemedicine Consultation
 The payment of a telemedicine consultation should be treated the
same way as the in-personconsultations.2
 The healthcare provider shouldgive areceipt or an invoice tothe
 Patient for the fee charged.2
DUTIES AND RESPONSIBILITIES OF A RMP IN GENERAL (applicable to ob-gy also)-
MEDICAL ETHICS, DATA PRIVACY & CONFIDENTIAILITY

7.  Principles of medical ethics, including professional norms for protecting
patient privacy and confidentiality as per IMC Act shall be binding and
must be upheldand practiced.
 RegisteredMedical Practitioner would be required to fully abide by Indian
Medical Council (Professional conduct, Etiquette and Ethics) Regulations,
2002 and with the relevant provisions of the IT Act, Data protection and
privacy laws or any applicable rules notified from time to time for
protecting patient privacy and confidentiality and regarding the handling
and transfer of such personal information regarding the patient. This shall
be binding and must be upheld and practiced.
 RegisteredMedical Practitioners will not be held responsible for breach of
confidentiality if there is a reasonable evidence to believe that patient’s
privacy and confidentiality has been compromised by a technology breach
or by a person other than RMP. The RMPs should ensure that reasonable
degree of care undertakenduring hiring such services.
MISCONDUCT
It is specifically noted that in addition to all general requirements under the MCI
Act for professional conduct, ethics etc, while using telemedicine all actions that
willfully compromise patient care or privacy and confidentiality, or violate any
prevailing laware explicitly not permissible.
Some examples of actions that are not permissible:
 RMPs insisting on Telemedicine, when the patient is willing to travel to a
facility and/or requests anin-personconsultation
 RMPs misusing patient images and data, especially private and sensitive
in nature (e.g. RMP uploads an explicit picture of patient on social media
etc)
 RMPs who use telemedicine to prescribe medicines from the specific
restrictedlist
 RMPs are not permitted to solicit patients for telemedicine through any
advertisements or inducements
CERTAIN IMPORTANTPOINTS FOR OBSTETRICIAN&GYNECOLOGIST:
 Obstetrician–gynecologist’s ability to communicate information
effectively and compassionately is key to a successful patient–physician
relationshipinpregnant patients.

8.  Synchronous modalities have the advantage of immediate, clear, and
accurate informationin real-time like video conferencing can allow for the
exchange of verbal and nonverbal cues, which forms base for effective
patient–physician relationship.
 Doctor should teleconference in a quiet professional environment and
should dedicate time specifically for video conferencing patients, as if the
patient were physically present.
 Doctor should offer the same level of care to patients receiving
telemedicine as they provide topatients inperson.
 Doctor should follow the same treatment guidelines they would follow
for in-person visits and should comply with applicable laws and
regulations and should examine their state laws and medical board
definitions closely and periodically to ensure that their practices are
compliant.
 There are many liability insurance options for physicians so before
choosing a liability insurer, physicians who provide telehealth should
request proof in writing that the liability insurance policies cover
telemedicine malpractice and that the coverage extends to other states in
which they are practicing, if applicable.
 Additionally, physicians who provide telehealth should check with liability
insurers for requirements or limitations to the provision of telehealth
services under the insurance policy. Requirements or limitations should
be documented clearly and physicians who provide telehealth should
weighrisk versus the benefit of policy.
 Telemedicine will reduce the time of consultations and improve the
quality of healthcare services in rural areas, removing many of
infrastructural challenges. The telemedicine market in India is expected to
reachUS$5.4 Bn by 2025 withaCAGR of 31%.
Do’s and Don’t’s for Doctors:
1. Patient identificationis mandatory during first consultation:

9.  At first consultation of the patient - ask patient’s name or age or address
or email I.D. or phone number or any other identification
 Patient identity confirmation is not mandatory during follow-up
consultation, but may be carried out on need basis: It is not mandatory to
identify the patient during a follow-up teleconsultation with a known
patient, especially if the doctor is communicating through the registered
user id, email idor phone number.
 In case of doubt, the doctor should confirm patient identity as during the
first consultation.
2. Caregiver identity andauthorizationshouldbe checked:
 If the patient is not a minor or is not incapacitated, then a caregiver
cannot consult on behalf of the patient unless he or she has a
formal authorization such as a signed authority letter by the patient
or his/her legal representatives (family members) or, where the
caregiver is a family member himself or herself, if he or she has a
document that verifies his or her relationship with the patient such
as a government identity proof.
 The caregiver’s identity and authorization should be checked by the
doctor before offering teleconsultation.
 In the case of minors, the identity of the caregiver should be
confirmed.
3. Doctor should identify himself/herself to the patient before start of every
teleconsultation:
 A doctor should begin any teleconsultation by informing the patient
about his/her name and qualification. This may be uncomfortable
to be done every time, especially toaknown patient.
 This is the requirement of Telemedicine Guidelinesat present.
4. Doctor should display his/her registration number at every touch-point
withpatient:
A doctor who provides teleconsultation is required to display his/her
registration number provided by respective State Medical Council on
his/her prescription, website, electronic communications

10. (WhatsApp/Message/Email etc.) and fee receipts given to his/her
patients.
5. Doctor shouldnot continue withteleconsultationif it not appropriate:
If the doctor is not satisfied with the information provided by the patient
to provide specific treatment, i.e. prescription or health advice, then
he/she should provide limited consultation as appropriate and refer the
patient for an in-personconsultation.
6. Doctor shouldmaintain patient records of teleconsultation:
 For in-person O.P.D. consultations in India, the doctors, in general,
do not maintain patient records. Appropriate patient history,
observations and findings are recorded on the prescription and it is
handed over to the patient.
 But or teleconsultation, it is mandatory for doctors to prepare,
maintain and preserve the patient’s records (e.g. case history,
investigation reports, images, etc.), copy of prescription issued and
proof of teleconsultation (e.g. phone call history, email records,
chat/ text record, videointeractionlogs etc.).
 Generally recommendedtomaintainthese records for three years.
7. Patient’s personal data should not be disclosed or transferred without
writtenconsent of the patient:
 Since teleconsultation happens on an electronic medium, the Indian
law that protects personal information including medical and
health-related information of patients, squarely applies to doctors
who provide teleconsultation and receive such information from
patients.
 This is in additionto the ethical obligationto protect patient privacy
that is recognized inthe Code of Conduct.
 The most important thing to note here is that Doctors who provide
teleconsultation should not disclose or transfer any information
that may identify the patient without the prior written consent of
the patient.

11. 8. Doctor should not deny emergency teleconsultation, but limit it for
immediate assistance or first aid:
o Emergency teleconsultation should not be provided remotely
except when it is the only way to provide timely care. Even then,
such emergency teleconsultation should be limited to first aid, life-
saving measures, counselling andadvice onreferral.
o Every emergency teleconsultation must end with an advise to the
patient or his/her carer for in-person interaction with a Doctor at
the earliest.
9. Limitationon prescribing medicines topatients:
The most significant limitation imposed by Telemedicine Guidelines on
the practice of telemedicine in India. In order to prevent abuse, the
Telemedicine Guidelines require every doctor to “prescribe medicines via
telemedicine ONLY when (the doctor) is satisfied that he/ she has
gathered adequate and relevant information about the patient’s medical
condition and prescribed medicines are in the best interest of the
patient.” Prescribing Medicines without an appropriate
diagnosis/provisional diagnosis will amount toprofessional misconduct.
10.Before issuing a prescription through teleconsultation, every doctor is
supposed to inquire about the age of the patient. If there is any doubt
about the age of the patient, thenthe doctor should seek age proof. If the
patient turns out to be a minor, then further teleconsultation should be
done and prescription should be issued only in the presence of an adult,
whose identity shouldalsobe ascertainedby the doctor.
11.If the teleconsultation with the patient does not take place over video,
then the concerned doctor cannot prescribe drugs to the patient other
than common over-the-counter (“O.T.C.”) medications such as
paracetamol, O.R.S. solutions, cough lozenges etc. Such patient also
cannot be prescribed medication for which diagnosis is possible only by
video consultation such as antifungal medications for Tinea Cruris,
Ciprofloxacillineye drops for Conjunctivitis etc.
The doctor may, however, prescribe ‘add-on’ medication to such patient
to optimize the existing treatment through drugs if such existing

12. treatment was prescribed in an in-person consultation less than six
months ago.
Very important to note here there is no bar in prescribing emergency
medications, even if they are not O.T.C. medicines, as and when notified
by the government, through any form of teleconsultation, whether video
or not.
o List O – common OTC medicines - can be prescribed without video
teleconsultation
o List B - A list of ‘add-on’ medications to optimize existing treatment
is described
o List O - emergency medications would be included in the list of
O.T.C. medications, i.e. If the patient is examined through video,
then the doctor may prescribe medications other than O.T.C.
medicines described inList A of Appendix 5 of Code of Conduct.
o
Some examples of suchmedicines are:
 Ointments/Lotion for skin ailments: Ointments Clotrimazole, Mupirocin,
Calamine Lotion, Benzyl Benzoate Lotionetc.
 Local Ophthalmological drops such as: Ciprofloxacillin for Conjunctivitis,
etc
 Local Ear Drops such as: Clotrimazole ear drops, drops for ear wax etc.
12.The doctor may also prescribe a ‘refill’ of medication already prescribed
during an in-person consultation for chronic illnesses (hypertension,
diabetes, asthma etc.) or an ‘add-on’ medication to optimize the existing
treatment (like inthe case of non-videoconsultation).
13.No doctor is permitted to prescribe habit forming drugs (i.e. drugs in
Schedule X of Drugs and Cosmetics Rules, 1945) or narcotic or
psychotropic drug (i.e. drugs regulated by Narcotic Drugs and
Psychotropic Substances Act, 1985) through any medium of
teleconsultation.
MANDATORY TRAINING IN TELEMEDICINE
 At some point of time in future, the Board of Governors in supersession of
Medical Council or National Medical Commission would introduce training
programs in telemedicine.

13.  It will be mandatory to participate in those training programs for all
doctors who intendtooffer teleconsultations topatients.
 However, until those training programs are developed, there is no
restriction in terms of prior training or qualification for registered doctors
to engage in teleconsultation.
The Telemedicine Guidelines do not apply to practitioners of Ayurveda, Yoga,
Homeopathy, Unani or Siddha.
Impact of 2018 judgement of Deepa Sanjeev Pawaskar and Anr. v. State of
Maharashtraon Telemedicine Practice Guidelines
In 2018, a judgement of High Court of Bombay caused panic amongst doctors
who offered teleconsultation. In that case, two gynaecologists were denied
anticipatory bail on the grounds that, prima facie, they were criminally
negligent towards their patient who unfortunately died while under their care.
The material facts of the case are that the deceased patient had presented
herself with a complaint of fever and severe vomiting. She was admitted to the
nursing home of the accused doctors by the hospital staff without examination,
as the doctors were out of town. One of the doctors started treatment for the
patient telephonically, by instructing the on duty nurse. Unfortunately, the
patient died. The Court held that the patient died because, amongst other
things, she was prescribed treatment over telephone without appropriate
diagnosis, and found such practice to be an act of criminal negligence. The
application of the doctors for bail in anticipation of arrest was rejected.
However, the doctors were successful in receiving the bail in appeal and were
not arrested.
This judgement was interpreted by some doctors as deeming the practice of
telemedicine and teleconsultation itself illegal. However, such an interpretation
is without basis and incorrect. The Court was only concerned failure of the
doctor to diagnose the patient. The fact that the drugs for treatment of patient
were communicated by the doctor through telephone is only incidental to the
outcome of the judgement. It is not the basis of the judgement. In other words,
had the doctor communicated the same drugs to the nurse orally while being
physically present but without examining the patient, and then patient would
have died, the Court would have come to the same conclusion. Thus, the
judgement should not be extrapolated to state that the practice of telemedicine
and teleconsultationitself is illegal.

14. Therefore, the above judgement of Bombay High Court does not interfere with
the Telemedicine Guidelines at all. In fact, it supports it. The Telemedicine
Guidelines require doctors who provide teleconsultation to start patient
treatment only if the doctor is satisfied that he/ she has gathered adequate and
relevant information about the patient’s medical condition and prescription of
medicines which are in the best interest of the patient. Else, the doctor should
not prescribe medication to the patient. If the doctor prescribes patient in
violation of the Telemedicine Guidelines, he/she risks losing his/her registration
with respective State Medical Council i.e. the license to practice medicine on
grounds of professional misconduct.
ENFORCEMENTOF THETELEMEDICINEGUIDELINES
 The Telemedicine Guidelines have been published in form of an
amendment to the Code of Conduct. Therefore, any violation of the
Telemedicine Guidelines will be looked at as a ‘misconduct’ at hands of
the concerneddoctor under the Code of Conduct.
 A patient, who suffers due to misconduct, has the right to complain to the
respective State Medical Council with whom the doctor is registered
about the misconduct.
 If the doctor is found guilty of the misconduct, he or she may be
reprimanded, or his/her registration may be suspended or cancelled. A
suspension or cancellation of registration would effectively stop the
doctor from carrying on his/her medical practice.
CONCLUSION:
 The notification of the Telemedicine Guidelines marks the dawn of a new
erain the practice of modernmedicine.
 The law has finally caught up with the reality and necessity of modern
times.
 The Telemedicine Guidelines enable doctors to confidently provide
teleconsultation via any medium (such as email, phone call, message, fax,
WhatsApp, other mobile and computer applications such as Skype,
Google Hangouts etc.) to the patients.

15.  At the same time, they protect patient interest by mandating doctors to
identify themselves before consultations, disclose their registration
number, and offer the same standard of care to patients as during in-
person consultation and limit medicines that can be prescribed through a
teleconsultation.
 Indians will now be able to enjoy access to quality healthcare remotely,
and doctors will be able to extend their services to many more needy
patients.