The Practice of Telemedicine: Medicolegal and Ethical Issues
Lateef, Fatimah, Ethics & Medicine
Generally, the medicolegal position of doctors in telemedicine (TM) consults is similar to telephone, fax, email, or communications by letters. All these amount to the provision of advice from a distance but where the usual standards of care and skills must apply. Patients permission, ethics and confidentiality issues still predominate, whilst right to privacy and autonomy must be maintained. TM places obligations on both distant and local providers. With time, the patient (also the consumer here) must become more educated about the nature, purpose, and use of equipment as well as both what TM can offer and its limitations. Any potential breaks in confidentiality must be addressed to enhance the level of patient satisfaction and maintain excellent standards in healthcare.
With all the challenges facing the healthcare industry today, the burgeoning old and new mix of diseases, increasing public and patient expectations, as well as the evolution of technology, it appears healthcare personnel cannot run away from practising some degree of telemedicine. The gradual birth of telemedicine can be traced to advances in electronic modes of communications, radio, television, and personal computer usage.1,2
Telemedicine literally means the practice of "medicine at a distance", beyond geographical boundaries, i.e. the delivery of healthcare and the exchange of health information across distance. It encompasses diagnosis, treatment, prevention, continuing education, research, and evaluation. TM allows rapid access to shared and remote medical expertise by means of telecommunications and information technology, no matter where the patient or relevant information is located.1'3,4 It can enhance communications up and down the healthcare pyramid (Fig 1). 1
TM should be differentiated from telecare, which is defined as the provision of nursing and continuing support to patients at a distance, and telehealth, which is public health services delivered at a distance to people who are not necessarily unwell. All three have the common basis of requiring telecommunications networks.
Practice of Telemedicine
Today, there are many modalities of TM already in use and in different applications:3'5
1. Pre-recorded: this information is used in teleradiology, telecardiology, teledermatology, and telepathology
2. Real-time: this can be in the form of images (eg. telepathology, teleradiology, and emergency medicine) or videos (eg. telepsychiatry, teledermatology, teleENT, emergency medicine, tele-oncology and teleneurology). It is also applied in prehospital medical care in which paramedics communicate with doctors and medical control for advice and conveyance of information
3. Tele- education: this can be at different levels such as undergraduate, post-graduate, instruction for residents and trainees as well as part of continuing medical education for doctors and healthcare professionals
TM can be classified according to:
1. The type of interaction, i.e. between patient and doctor, between doctors or different specialists, or
2. The type of information being transferred, i.e. data, text, still images ( radiological images like X-Rays and scans or clinical photos) or moving images (video). These data and information can be pre-recorded and then transmitted or transmitted directly in real time.
The essential components of the TM system which will help to ensure it works and is sustainable, include:
a. Adequate and suitable personnel who are trained, familiar, and have ownership of the system and programmes,
b. The relevant technology, which will have to take into account the type of information to be transmitted, the speed of transfer, the quality as well as size of information to be transmitted, and
c. One or several champions for the programme. These are trained persons committed to oversee the system and encourage others as well as keep them motivated. They can help with compliance and other teething issues, especially in the early phases of implementation.
Another consideration is whether to include audio capabilities, documents and text, still images, or moving images (video). As information is captured, the type and mode of display must also be decided. Issues such as resolution, clarity, and quality become important.6
The Medico-Legal and Ethical Issues
The standard of clinical practice must apply regardless of whether the technology is used or not. Therefore, the intervention of the technology does not reduce the obligation to meet standards, and failure of the technology does not mitigate the failure to meet the standard. This must motivate us to ensure the equipment is reliable, the technical specifications are adequate, and backup hardware and software are available. Whilst the benefits of telemedicine are known, many are still reluctant to engage in the practice due to unresolved legal and ethical concerns. The tenets of professional conduct and physician-patient relationship must be upheld when using electronic communications or telemedicine. These should include record-keeping, provision for physical examination and confidentiality. As TM is a very promising field that will increasingly become incorporated into medical practice, it is important to clarify doubts pertaining to the ethics of its practice. Institutions and organisations where this is practised must provide an ethical-legal framework within their current laws, statutes, and medical standards that will guide professionals. This is also an important step for upholding public and patient trust.7-9
Physicians practising telemedicine must be authorised to practise medicine in the country or state where they are located and must be competent in the field of reference. This is one of the initial and most fundamental considerations. When practising telemedicine directly with the patient, the doctor must be authorised to practise medicine in the state where the patient is normally a resident, or the service should be internationally approved. Similarly, the decision on practice insurance coverage will have to follow licensure.
According to the Joint Commission Accreditation, Medical Staff Standards on TM9, practitioners who diagnose or treat patients via telemedicine link are subject to the credentialing and privileging processes of the organization that receives the TM service (MS 5.16).
Use of TM must be based on mutual respect, the independence of judgment of the doctor, the autonomy of the patient, and professional confidentiality. In emergencies, judgment may have to be based on less complete information but in these cases, any danger to the health of the patient will be the determinant factor in the provision of advice or treatment. The doctor asking for another doctor's advice remains responsible for the treatment, any decision, and recommendations given to the patient. When there is direct doctor-patient relationship in TM, the doctor is responsible for the case in question. The doctor performing medical intervention via TM equipment is responsible for these interventions.
A doctor practising TM is responsible for the appropriate quality of his or her service. It must be of sufficiently high standard, and it must be adequately operational. All doctors must keep adequate records of patients and cases consulted. Patient identification, quality and quantity of data, findings, recommendations, and management must be documented. Storing and transmission methods must also ensure that confidentiality and security are guaranteed.
The introduction of emergency TM raises unique legal and ethical situations. However, the fundamental nature of the clinical consultation remains unchanged and must conform to the principle of safety and excellence in healthcare.2 In emergency care, judgment may be based on incomplete information, but this is similar to other emergent situations in which patients may be non-communicative or may have an altered mental state. Emergency TM has been shown to have the ability to change patient management and outcomes indicator10. Thus, important considerations include real-time quality, low-latency audio-visual communications, time -sensitive issues and consults between hospitals, and the hospital and pre-hospital environment.10,14
Emergency departments offering TM services must ensure these are given due consideration in their clinical workload as TM consults may take longer than standard ones. Accurate activity records must be maintained, especially to justify need for increased manpower as necessary. At the end of the day, those using this service must be aware of the advantages as well as the limitations.15-17
The potential new clinical risks opened up by the world of telemedicine include the following:14
1. Teleconsultants acting beyond ability
2. Ensuring the quality of the materials transmitted e.g. photos, videos, slides, radiographs, data
3. Improper or negligent delegation of tasks and responsibilities
4. Poor or inadequate training and skills
5. Unclear delineation of responsibilities
6. Subnormal standard equipment
7. Communications problems
Other issues to be considered are the possibility of fraud and abuse and copyright, trademarks, and intellectual property rights.
It is thus important for physicians practicing telemedicine to ensure that:
a. They give all the necessary information to the patient and family,
b. They answer all the patient's concerns and questions, and
c. They give the patient the opportunity to refuse or limit their consent where applicable.
In some countries there may be other Bills, laws or Acts which will lend support, such as those applicable in the UK below:
Data Protection Act 1998 18
Computer Misuse Act 1990 19
Access to Health Records Act 1990 20
Access to Medical Records Act 1988 21
Institutions may set up standards related to credentialing and privileging of TM. In general, practitioners can provide either 'interpretive service' or 'consultations.' The former is the official reading of images, tracings, or specimens through TM link e.g. radiologist, pathologist. This is done in real time or transmitted by storing and then forward technology. Consultation services offer expert opinions and/or advise the treating physicians.
Perhaps the best suggestion for the institutions using or planning to set up TM services would be to set up or tie up with an ethics training centre. The centre can have programmes and training which help with clarification, understanding, and management of social, legal, and ethical problems which may arise. It can also be used to help to train researchers possessing knowledge and skills in the domains of ethics, law, and sociology, relating to the use of information and communications technologies and networks in healthcare. With modernization and increasing technological sophistication, research funded by Information Technology companies has to be selected with caution as some may have a vested interest.22
Many will ask the question: if we are indeed using telemedicine, what are the appropriate clinical and technical standards we should adopt? No one will disagree that standards must be addressed by rigorous risk assessment backed by evidence as much as possible. Standards in most branches of medical practice are set by the professional organizations that govern the relevant specialities, such as the Royal Colleges in the UK. Until today, no formal professional organization has been convened for teleconsultants. Coordination between specialists and professional organizations is essential if compatible technical and clinical standards are to be adopted and understood by all. Only then can there be some harmonization of these standards.
Security and Confidentiality
The principle of confidentiality that has been at the heart of medical ethics since the time of Hippocrates applies to TM just as it does to the conventional way of practice. Patients have a right to expect that one will not disclose any personal information, in the course of one's professional duties unless they grant permission. Electronic patient records and health records transmitted over national and international networks offer unprecedented opportunities for healthcare but pose complex challenges to confidentiality. Unauthorised users could attempt access to a computer system connected to a network illegally and even intercept transmission at times. Most systems are now password-guarded, and institutions must clearly demarcate the boundaries between the person who has access and the one who does not. There may also be special protection for 'sensitive personal data', and access to such information is only possible when certain safeguards are imposed.
When we use computer networks for communications in healthcare, we need to be able to digitally 'sign' documents in a way that guarantees the sender that documents can only be read by the intended recipient (confidentiality). It also needs to inform the recipient who the document is from (identity) and reassure them that the document has not been altered in any way (integrity). This is now being done through the use of encryption methods. Digital signatures can indeed be useful in many instances, but their utility also greatly depends upon the legal acceptability of electronic documents.
Responsibility in Telemedicine
The responsibility in TM should be viewed as involving three fundamental relationships:
a. The relationship between clinician and patient
b. The relationship between clinicians (e.g. specialists, general practitioners, and nursing staff), and
c. The relationship between the provider of the TM system and the user (clinician and patient).
In each of these relationships there is a duty owed by one party to another. The situation may be complicated by the involvement of multiple clinicians and the of the TM system itself from a number of components such as the call centre, the telecommunications network, and the various types of hardware and decision support software (including databases and algorithms) that makes the system work. There are also a number of separate organizations involved in the manufacturing, installation, maintenance, and operations of the system. Thus in the events where harm to a patient arises during teleconsultation, a number of these organisations or individuals will be defendants to a legal action for negligence if it is unclear what went wrong and where the responsibility lies.
Conducting telemedical consultations across national borders raises the interesting, complex, and practical question: which country's law applies to the cross-border communications? Oftentimes it must be the country which has the most real and substantial connection to the case. Other factors would include the availability of witnesses, conveniences, expenses and residence of the parties involved. If the defendant is ordinarily a resident of a European country, jurisdiction is governed by the Civil Jurisdiction and Judgements Acts of 1982. This act provides for proceedings to be issued in a defendant's country of residence (the 'primary jurisdiction') or the place where the harmful event occurred (the 'alternative jurisdiction').23
State-based licensure systems for clinicians are structured around certain national standards. These standards have evolved in a profession in which physicians trained in one country travel and practice in another where they have been accepted. Often this has to come with obtaining an endorsement to practice in the new country through taking additional examinations or qualifications tests and often overcoming some bureaucratic hurdles of the receiving country. Meeting these requirements can indeed be a daunting and substantial task for individual teleconsultants to undertake and repeat in every country in which they wish to practice this.23,24
Telemedicine is another technological advance that physicians and patients will embrace in our never-ending pursuit of the restoration and maintenance of optimal health. The field is rapidly changing, but tenets of professional conduct must be upheld and applied to the practice. Barriers to the expansion of telehealth industry can be overcome with a positive outcome as long as they are approached with the right attitude, mindset, and understanding of the issues concerned. While in many respects the legal and ethical aspects of the patient-doctor relationship remain unaltered, new and innovative ways of conducting this relationship from a distance do require us to change not only the process of healthcare but also the way in which we regulate it. If we need to seriously consider addressing the healthcare disparity issues and inequality of distribution, then health informatics and telematics technologies must be fully exploited to our and our patients' benefits. To overcome barriers of this exploitation, global cooperation between governments, professional bodies, and healthcare systems need to be commenced sooner rather than later.
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FATlMAH LATEEF, MBBS, FRCS
Fatimah Lateef, MBBS, FRCS, is Senior Consultant and Director of Undergraduate Training and Education in the Department of Emergency Medicine at Singapore General Hospital and Is Senior Clinical Lecturer in Yong Loo LIn School of Medicine at the National University of Singapore, SINGAPORE.
Fatimah Lateef, MBBS, FRCS, is Senior Consultantand Director of Undergraduate Training and Education in the Department of Emergency Medicine at Singapore General Hospital and is Senior Clinical Lecturer in Yong Loo Lin School of Medicine at the National University of Singapore, SINGAPORE.…
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Publication information: Article title: The Practice of Telemedicine: Medicolegal and Ethical Issues. Contributors: Lateef, Fatimah - Author. Journal title: Ethics & Medicine. Volume: 27. Issue: 1 Publication date: Spring 2011. Page number: 17+. © Bioethics Press Fall 2008. Provided by ProQuest LLC. All Rights Reserved.
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