Teleconsultation – Legal Aspects
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Authors
Name | Affiliation | |
---|---|---|
Rafał Patryn |
Department of Sociology of Medicine, Medical University of Lublin, Poland |
|
Mariola Drozd |
Department of Ethics and Medical Law, Medical University of Lublin, Poland |
In the context of the recently adopted law,
teleconsultation is a new solution for mutual communication between the doctor
and the patient. The introduced legal provisions are to improve contact with
the doctor and his or her availability for the patient as a person in need of
help. Such form of advice, or consultation is right now a health service
provided by the doctor over distance using electronic communication channels
(online, telephone). The epidemic safety means and the recommendations
concerning caution in contacts with others during the ongoing COVID – 19
pandemic are key. The doctor, owing to the specific nature of the profession,
is particularly exposed to the risk of infection from the patients or the
places where he or she must stay. In order to counteract the COVID – 19
pandemic, new legislation has been introduced such as the
Act of 2 March 2020 on special solutions related to preventing, counteracting
and combating COVID-19, other infectious diseases and crisis situations caused
by them and its later amendment of 31 March 2020, as well as the Regulation of the Minister Health of 12
August 2020 on the organizational standard of a teleconsultation within primary
health care. The
legal provisions included in these acts are related to the principles of
providing health services by doctors in the form of a teleconsultation. The act
determines and clarifies what a teleconsultation is, as a form of a mutual
communication channel between the doctor and the patient, and the regulation
applies to health services provided in this way within primary health care
(POZ, family doctors), by POZ doctors. For the doctor, the changes introduced
in the law are important, because they determine the new formula of providing
health services, the way they are provided and the manner this fact is recorded
in the medical documentation.
Introduction
Telemedicine, understood as a teleconsultation
(consultation over the phone), an on-line consultation, video-conference, instant
messaging (IM) or e-mail is currently the most common form of doctor - patient communication. This technological
development has been applied in Europe and the States for a long period of time
(decades even); in Poland it was only the Covid-19 pandemic that forced its
implementation and practical application. What should be emphasized, apart from
the obvious pragmatics and easiness of use, it is safe in terms of the doctor
patient direct contact, which in the times of pandemic is of pivotal
importance.
The dynamic COVID-19 pandemic has caused big changes in the functioning
of the medical area. Consultations given by a doctor over distance via
electronic means (on-line, telephone) have become a fact. This form of contact
was differently treated before the pandemic, however,
presently, safety measures and caution in contacts with other persons are a
priority.
Undoubtedly,
medicine recommends limiting direct contacts to those required by the patient's
health condition and the need for a specific medical intervention. In other
cases, the use of electronic devices to obtain medical aid is currently a
standard and, what should be emphasized, is safe for both sides; the doctor and
the patient, as well as their family members and friends. In exercising his or
her profession, the doctor is particularly exposed to the risk of patient-derived infection. Teleconsultation, namely a
health service provided over distance by means of various communication systems,
is a compromise between the doctor's work safety and his or her accessibility to
patients and the possibility to offer consultations to them.
Currently,
telephone or on-line consultations are used not only in many European countries
but all around the world. [1]
In countries such as Great Britain, Denmark, Switzerland, USA, this form of
communication has started to be implemented as an alternative to the form of
direct doctor-patient contact, and now its use has become a fact. The system of
electronic or telephone forms of communication is accessible and easy to use.[2] Especially in the era of a
pandemic, the possibility of treating patients with telemedicine increases
significantly. However, it is necessary to undertake harmonized actions, i.e.
centrally coordinate reporting and communication systems that facilitate crisis
management. [3] In Denmark,
telemedicine system has proved flexible in adapting to new challenges.
Hospitals have been fully computerized with
on-line medical records of patients and a digital mechanism for submitting
prescriptions to pharmacies.[4] Telephone consultations in Great Britain are a
part of the universal health system. In Australia, telemedicine is currently
available through the Medicare Benefits Schedule for specialist services and
disease management through videoconferences held by doctors of various
specialties (psychiatrists, occupational medicine physicians, and palliative
medicine specialists). Telemedicine as a form of a segregating system facilitates
the assessment of patient's health condition and his/her referral to an
appropriate doctor and is important in responding to emergencies by providing
access to care for patients in remote locations. [5,6] In some situations, due to the lack of appropriate technological
solutions, doctors use private devices, e.g. in South Africa, doctors use their
own cell phones to care for their patients. In this context, the use of mobile
phones increased the availability of primary healthcare services.[7]
Physicians use these electronic devices to register patients, track their
health status, make decisions as to further treatment, and to communicate. The
challenges that doctors face included poor connection and poor access to
electronic communication channels.[8] The problem with the implementation
of telemedicine is noted in low and middle income countries. There is no large
scale apps or services and the most frequently documented method of
communication was the use of one – way text messages and telephone reminders on
the date of follow-up visits.
Large-scale applications and services are
missing and the most frequently documented use of this form of communication
was one-way text messages and telephone reminders about the dates of follow-up
visits. [9] Consultations
and prescriptions via mobile phones are extremely common in pediatric offices.
However, there is a need for proper oversight of these regulations and the
involvement of those at interest i.e. as pediatricians and pharmacists.[10]
Online consultations in Canada are becoming more common and have the potential
to modernize the way healthcare is delivered. Here, too, various contexts are
analyzed including the ethical one. The need to implement measures to reduce
the risks to which the patient may be exposed is noted. [11] Telemedicine can
also prove convenient to patients with discrete health problems and relieve
general practitioners. [12] The current situation has contributed to the
popularization and direct use of this form of contact, i.e. in Poland. However,
until recently it has been argued that deontological records create a
traditional form of doctor- patient contact and diagnosis and advice provided
at a distance is to be given in exceptional situations. Undoubtedly, this form
of contact is new to Polish doctors. Once established, it can be the subject of
research and comparison to the systems of other countries that introduced
telemedicine much earlier.
What is more, it will also be possible to determine its quality in
comparison to traditional treatment methods.
In order to counteract the COVID – 19 pandemic, new legislation has been
introduced. These include the Act of 2
March 2020 on special solutions related to preventing, counteracting and
combating COVID-19, other infectious diseases and crisis situations caused by
them and its later
amendment of 31 March 2020 (hereinafter
referred to as the Act), as well as the Regulation of the Minister Health of 12
August 2020 on the organizational standard of a teleconsultation within primary
health care (hereinafter referred to as the Regulation). These acts define the principles of granting health services in
the form of a teleconsultation [13]. The Regulation introduced in August this
year applies to providing health services within primary health care as defined
in the Act of 27 October 2017 on primary health care [14]. For the doctor, the changes introduced in the law are
very important, because they bring into play a new formula of providing health
services and new elements of consulting procedure.
Formal Basis for Conduct
of a Doctor Providing a Teleconsultation
The
solutions introduced to the Polish law, intended to counteract the pandemic
caused by the SARS-CoV-2 virus, are included in the quoted Act [15,16]. This legal
act sets out the rights and obligations of service providers (doctors,
hospitals, medical entities) in the scope of preventing and combating
infectious diseases caused by this virus. Teleconsultation means a health
service provided over distance by an authorized person (a doctor) using data
communication systems (the Internet) or communication systems (telephone).
Teleconsultations may be granted by entities involved in medical operations, as
well as by doctors (and dentists) using the data
communication system provided by the entity competent in the scope of health
care information systems. Then, it is necessary for the doctor to keep
simplified medical documentation in the form of a teleconsultation card
containing:
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designation of the patient: name and surname, PESEL number (in case of its
absence, the series and number of another document confirming identity), date
of birth, sex, e-mail address, contact telephone number.
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designation of the person providing the teleconsultation: first and last name,
occupational title, number of the license to exercise the regulated profession.
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information about the patient's health condition and the recommended diagnostic
and therapeutic process, identification of the disease or health problem,
recommendations.
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information about any issued certificates, recipes or referrals, other
information significant for the treatment process.
Requirements and standards of
Teleconsultation
The
provision of health services in the form of a teleconsultation is a new formula
of mutual relations between the doctor and the patient, which is naturally
still being developed and particularized at the present stage, in terms of the
area and the scope of the service provided in this way [17,18]. It is worth
adding that, on the basis of Article 22, item 3b of the Act of 15 April 2011 on therapeutic
operations, the Competent Minister for
health, in consultation with the Competent Minister for IT development, has
determined, in the Regulation, the
requirements which should be fulfilled by rooms and devices, as well as data
communication systems or communication systems of the entity involved in
medical operations providing only ambulatory health services using data
communication systems or communication systems [19]. The Regulation of the Minister of Health of 12 August
2020 applies to the standard and the organizational principles of the so-called
teleconsultation within primary health care
(POZ, family doctors) [13]. Such advice may be given by a doctor in a
primary health care entity mentioned in Article 9 section 1 of the Act on primary health care [20].
Primary health care is the place of the first contact of the beneficiary (the
patient) with the health care system, except for situations when the
beneficiary is in a condition of a sudden health hazard or any services are
provided to them where access to preventive, diacritic, medical, nursing, as
well as rehabilitation health care services financed from public funds is
ensured [20]. The implementation of effective communication between the patient
and the doctor requires a definition of the components, such as the
organizational standard and the principles of a teleconsultation provided under
POZ. Such elements include the obligation to notify the parties involved about
the details and the conditions of providing teleconsultations. This obligation
is to be fulfilled by posting an announcement at the place of performing the
services by the POZ entity, on its website and by phone (if necessary). The
information is to specify the data communication systems or communication
systems by means of which the service provider conducts teleconsultations (e.g.
online, email, phone, audio-video system, Zoom) and the method of setting the
date of a teleconsultation. Through
legislation, there is a specified way for the doctor to initiate contact with
the patient in order to provide a teleconsultation and a specified way to
provide it. At a specific time, including the day and the hour, the doctor makes
him/herself available for the patient using a particular communication device.
This can be an audio (telephone) or an audio and video (e.g. video messenger
such as Zoom) communication device, and a teleconsultation may be granted in
the form of a phone consultation, a video chat, and, in justified cases, also
by e-mail (electronic mail). The person providing the teleconsultation should
precisely specify to the public the possibilities and the ways of performing
such a service, along with the phone numbers, e-mail addresses, login data, or
video chat access codes. In a situation when there is no contact with the
patient at the agreed time, the notification is canceled. However, before that,
the doctor is obliged to make an attempt, at least three times, to contact the
patient, for no less than 5 minutes [20]. It should be emphasized that, in the
event that, due to the patient's health condition, the health service cannot be
offered in the form of a teleconsultation, the patient is informed about the possibility
to use a health care service that involves direct contact with the doctor.
Naturally, such a procedure needs to be agreed with the patient or his or her
statutory supervisor (if the patient is in the legal situation of care).
Teleconsultation
is to inform the patient about methods of filling an e-prescription, e-referral
and e-order for medical products, methods of filling the order for additional
(laboratory, imaging) tests. Patients can set up an
Patient's online account (IKP) on the server of the Ministry of Health –
pacjent.gov.pl [21]. Persons registered IKP can receive e-prescription or/and
e-referral at the provided telephone number or e-mail address, and can share
with a relative personal information
about their health condition and the history of prescribed drugs. In this way,
he or she can also check e.g. coronavirus test results. Moreover, a relative or
a legally appointed person (statutory representative) can be authorized to
access the account. The service provider is obliged to notify the National
Health Fund about the phone number(s) under which teleconsultations are
provided.
The course of teleconsultation – patient’s
identification
A
doctor providing a teleconsultation, prior to granting it, is obliged to
confirm the patient's identity on the basis of the data mentioned in Art. 25
sect. 1 item 1 of the Act of 6 November
2008 on the patient's rights and the Patients Ombudsman [22]. In Article 25,
the Act enumerates the components of the medical documentation that are used in
this case to confirm the patient's identity. These include: surname and first
name (names), date of birth, sex, address of the place of residence, PESEL
number (in the case of a newborn – mother's PESEL number, and for any persons
who have no PESEL number assigned – type and number of the identity-confirming
document). In specific cases when the patient is a minor, a completely
incapacitated person or a person incapable of expressing consent deliberately,
it is necessary to verify the statutory representative's surname and first
name, along with the address of his or her place of residence [22]. This
information should be transferred by the patient using data communication
systems or communication systems (e.g. scan, picture, e-mail attachment).
Information confirming the patient's personal data can also be obtained on the
basis of information from the medical documentation, if the doctor has such
documentation, from the statement on doctor selection, as well as upon
presentation of an identity-confirming document while providing the service in
the form of a video consultation (a document presented to the video camera).
The course of teleconsultation –
providing healthcare services
The
person providing a teleconsultation is obliged to conduct it in the
circumstances that guarantee confidentiality (no access of persons unauthorized
to access the information communicated in this way). Based on the subjective
test and after analysis of the patient's available medical documentation, the
service provider should determine whether the health service granted in the
form of a teleconsultation is sufficient for the health problem being its
subject matter. This last is an important task of the doctor providing a
teleconsultation. If the nature of the current health problem prevents a health
service from being provided in the form of a teleconsultation, the doctor is
obliged to notify the patient about the need to gain such service via direct
contact, for example, during a traditional visit, also mutually agreed with
regard to day and time.
The course of teleconsultation –
medical documentation
After
the end of a teleconsultation, the doctor should generate a memo to be placed
within the medical documentation (kept in the form of a teleconsultation) about
the provided health service. Naturally, in the event that any information
concerning the patient's health condition is transferred, the data
communication systems and the technical and organizational solutions used by
the service provider should ensure integrity, safety and protection of any data
transferred electronically. Furthermore, all data collected (e.g. included in
the medical documentation) must be protected against destruction, loss,
unlawful disclosure or utilization. This applies to transmission of electronic
documents in graphic and text form. In the event of (if any) destruction, loss,
illegal disclosure or utilization of data, we will usually be dealing with the
so-called personal data protection violation. Such a breach may result in
material or immaterial damage for the person who has deposited the data. In
practice, this can relate to data theft, falsified identity, financial loss,
personal damages (discrimination, stalking, damage to reputation), as well as business
damages. The provisions of GDPR, along with their solutions, already have
relevance in this regard [23]. It should be emphasized that this act and the
sanctions it has introduced apply mainly to the failure to observe the
obligation to duly protect data (and not any effects of such failure) and offer
a possibility to impose monetary administrative fines in a fixed amount to the
personal data controller in a specific medical entity.
Discussion
In order to counteract the effects of the SARS-CoV-2
virus, special solutions have been introduced that are legally stipulated. In
the discussed case, due to the epidemiologic safety and more effective
availability of doctors than in the traditionally contact form, the possibility
has been introduced to offer a teleconsultation using electronic means and
distance communication.
Not a lot of time has passed since teleconsultation was introduced into
the polish medical reality, therefore it is difficult to find research based on
an objective assessment of the current situation. Information gathered on
patient forums vary; from positive to negative. Out of 40 000 complains
made to the Patient’s Ombudsman from the end of June 2020, 1 175 were made in
connection to teleconsultations. Doctors' views on telemedicine differ and the
previously cited studies show that they are usually positive with a lot of hope
for pragmatic innovations. This form of doctor-patient communication has its
limitations and specificity. It concerns the specialization of doctors
providing teleconsultation and the scope of such a medical service. Primary
care physicians talk differently with their patient, same as pediatricians
talks differently with mothers of a small children, and a specialist who has to
plan treatment based on provided data will also have to adopt a different
approach. In this case, it must be based on data such as the results of
diagnostic tests or a precisely described health condition, which may be
difficult in case of the used communication channel. Currently, as is also
noted in research conducted around the world, the limitation of the
effectiveness of teleconsultation is dictated by the specificity of the
patient's health. Difficult the
diagnosis, hindered contact with the patient or inadequate/ insufficient data
may cause the advice to be imprecise or faulty. Also, typical surgical medical
specializations expect different information from the patient than, for
example, a doctor who provides general advice.[24] Teleporting seems
appropriate to be used in specific cases, i.e. first contact doctors, general
advice, treatment continuity, prescription or general diagnosis. The doctors'
possible liability for providing a teleconsultation
that would be a misadvice and cause negative consequences for the patient's
health is also worth considering. An approximation of such a situation are the
circumstances of a diagnostic error that had come about through incorrect
description and assessment of the patient's health condition, and, based on
that, specific medical activities being conducted. In the present situation
of pandemic, the possibilities are
seriously being considered not to punish doctors for any decisions made in
connection with providing health services in the case of persons infected with
the SARS-CoV-2 virus. Naturally, such a solution must be well-considered in the
implementation so as not to result in mere ordinary impunity. However, in the current
situation, a doctor incorrectly providing teleconsultation may result, first of
all, in the termination of the POZ services agreement with the medical entity
and, second, the doctor may be subject to typical professional and civil
liability (liability for damages). Having this in mind, doctors must hold
themselves to high standards of professional conduct while providing a
teleconsultation. Such standards are described in the Act on the doctor's and the dentist's professions [25].
Therefore, it is worth remembering here that a teleconsultation should also be
provided according to the principle of due diligence and the principle of
up-to-date medical knowledge.
Conclusion
Legal sanctioning of teleconsultation as a new form of providing remote health services is important to both doctors and patients because of personal safety and much greater availability of this form of advice compared to visits in the traditional form in the times of pandemic. New technological solution for the doctor-patient relationship in the form of teleconsultation (and its various types) should aim to improve the effectiveness of healthcare services. However, it is a dynamic and constantly improving field, and its consolidation in medical practice will be a process that is primarily intended to effectively treat patients.
Authors declare none potential conflicts of interest.
Downes, M.J., Mervin, M.C., Byrnes, J.M. et al. Telephone consultations for general practice: a systematic review. Syst Rev 6, 128 (2017). https://doi.org/10.1186/s13643-017-0529-0
2. Blozik E, Wildeisen IE, Fueglistaler P, von Overbeck J. Telemedicine can help to ensure that patients receive timely medical care. Journal of Telemedicine and Telecare. 2012;18(2):119-121
3. Verhagen LM, de Groot R, Lawrence CA, Taljaard J, Cotton MF, Rabie H. COVID-19 response in low- and middle-income countries: Don't overlook the role of mobile phone communication. Int J Infect Dis. 2020 Oct;99:334-337. doi: 10.1016/j.ijid.2020.07.069. Epub 2020 Aug 4. PMID: 32763447; PMCID: PMC7402274.
4. Pedersen KM Andersen JS Søndergaard J. General Practice and Primary Health Care in Denmark. The Journal of the American Board of Family Medicine Mar 2012, 25 (Suppl 1) S34-S38; DOI:10.3122/jabfm.2012.02.110216
5. Bunn F, Byrne G, Kendall S. The effects of telephone consultation and triage on healthcare use and patient satisfaction: a systematic review British Journal of General Practice vol. 2005; 55: 956–61.
6. Bryan L. Burke, R. W. Hall and the SECTION ON TELEHEALTH CARE Telemedicine: Pediatric Applications. Pediatrics July 2015, 136 (1) e293-e308; DOI: https://doi.org/10.1542/peds.2015-1517
7. Anstey Watkins JOT, Goudge J, Gómez-Olivé FX, Griffiths F. Mobile phone use among patients and health workers to enhance primary healthcare: A qualitative study in rural South Africa. Soc Sci Med. 2018 Feb;198:139-147. doi: 10.1016/j.socscimed.2018.01.011. Epub 2018 Jan 10. PMID: 29335160.
8. Odendaal WA, Anstey Watkins J, Leon N, Goudge J, Griffiths F, Tomlinson M, Daniels K. Health workers' perceptions and experiences of using mHealth technologies to deliver primary healthcare services: a qualitative evidence synthesis. Cochrane Database Syst Rev. 2020 Mar 26;3(3):CD011942. doi: 10.1002/14651858.CD011942.pub2. PMID: 32216074; PMCID: PMC7098082.
9. Källander K, Tibenderana JK, Akpogheneta OJ, Strachan DL, Hill Z, ten Asbroek AH, Conteh L, Kirkwood BR, Meek SR. Mobile health (mHealth) approaches and lessons for increased performance and retention of community health workers in low- and middle-income countries: a review. J Med Internet Res. 2013 Jan 25;15(1):e17. doi: 10.2196/jmir.2130. PMID: 23353680; PMCID: PMC3636306.
10. Haddad RN, Sakr C, Khabbaz L, Azouri H and Eid B (2020) Telephone Consultation and Prescription in Pediatrics: Contributing Factors and Impact on Clinical Outcomes. Front. Pediatr. 7:515. doi: 10.3389/fped.2019.00515
11. Kobewka D, Forster AJ. On-line doctors: A disruptive innovation? Healthcare Management Forum. 2018;31(4):160-162. doi:10.1177/0840470418780022
12. Casey M. Shaw S. Swinglehurst D. Experiences with online consultation systems in primary care: case study of one early adopter site. British Journal of General Practice 2017; 67 (664): e736-e743. DOI: 10.3399/bjgp17X693137
13. Rozporządzenie Ministra Zdrowia z dnia 12 sierpnia 2020 r. w sprawie standardu organizacyjnego teleporady w ramach podstawowej opieki zdrowotnej. Dz.U 2020 poz. 1395
14. Ustawa o podstawowej opiece zdrowotnej. tj. Dz.U. 2020 poz. 172
15. Ustawa z dnia 2 marca 2020 r. o szczególnych rozwiązaniach związanych z zapobieganiem, przeciwdziałaniem i zwalczaniem COVID-19, innych chorób zakaźnych oraz wywołanych nimi sytuacji kryzysowych Dz.U. 2020 poz. 374
16. Ustawa z dnia 31 marca 2020 r. o zmianie ustawy o szczególnych rozwiązaniach związanych z zapobieganiem, przeciwdziałaniem i zwalczaniem COVID-19, innych chorób zakaźnych oraz wywołanych nimi sytuacji kryzysowych oraz niektórych innych ustaw Dz.U. 2020 poz. 568
17. Olszanecka-Glinianowicz M. Dudek D. Filipiak KJ., Krzystanek M., Markuszewski L. Ruchała M. Tomiak E. Leczenie nadwagi i otyłości w czasie i po pandemii. Nie czekajmy na rozwój powikłań – nowe wytyczne dla lekarzy.https://insulinoopornosc.com/wp-content/uploads/2020/08/wytyczne-dla-lekarzy-leczenie-otylosci-i-nadwagi.pdf
18. Rostkowska, J., Wojewódzka, D. (2020). Teleporady logopedyczne w czasie pandemii COVID-19 dedykowane dorosłym użytkownikom implantu ślimakowego. Nowa Audiofonologia, 9(1), 45-50. https://ojs.academicon.pl/na/article/view/3479
19. Ustawa z dnia 15 kwietnia 2011 r. o działalności leczniczej. t.j. Dz.U. z 2020 r., poz. 295
20. Ustawa z dnia 27 października 2017 r. o podstawowej opiece zdrowotnej t.j. Dz. U. z 2020 r. poz. 172
21. Ustawa z dnia 17 lutego 2005 r. o informatyzacji działalności podmiotów realizujących zadania publiczne Dz. U. z 2020 r. poz. 346, 568 i 695
22. Ustawa z dnia 6 listopada 2008 r. o prawach pacjenta i Rzeczniku Praw Pacjenta.t.j. Dz.U. 2020 poz. 849
23. Rozporządzenie Parlamentu Europejskiego i Rady (UE) 2016/679 z dnia 27 kwietnia 2016 r. w sprawie ochrony osób fizycznych w związku z przetwarzaniem danych osobowych i w sprawie swobodnego przepływu takich danych oraz uchylenia dyrektywy 95/46/WE (ogólne rozporządzenie o ochronie danych) https://uodo.gov.pl/pl/404/224
24. Prus K. Teleporada lekarska zawiodła. Miał być liszaj, grzyb a to była borelioza. https://www.dziennikwschodni.pl/zdrowie/teleporada-lekarska-zawiodla-liszaj-grzyb-a-to-byla-borelioza,n,1000272240.htm
25. Ustawa z dnia 5 grudnia 1996 r. o zawodach lekarza i lekarza dentysty tj. Dz. U. z 2020 r., poz. 514, 567.