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Telemedicine and the law

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VOL: 99, ISSUE: 21, PAGE NO: 50

Bridgit Dimond, MA, LLB, DSA, AHSA, is barrister-at-law and emeritus professor of the University of Glamorgan

Use of telemedicine in wound management
Use of telemedicine in wound management


The advantages of using telemedicine in health care were identified when the government launched a telemedicine website. Funded by the Department of Health, it is organised by the British Library Service in conjunction with Portsmouth University and provides information on:


- Organisations and people involved in telemedicine;


- Publications about telemedicine;


- Equipment used for telemedicine.


The Telemedicine Information Service (www.tis.bl.uk) aims to enable those working in telemedicine in the UK to share information. Its value in wound management is obvious. Doctors, dermatologists and health care professionals can see more patients and share their skills, without undertaking the time-consuming journeys necessary in many rural areas.


Many practitioners specialising in wound management have probably already been exposed to the uses of telemedicine. Hayes and Dodds (2003) discuss how telemedicine can be an effective resource in wound management. However, the following specific legal issues merit further exploration:


- Standards;


- Consent;


- Confidentiality;


- Data protection;


- Access;


- Documentation.


These areas will be considered in the light of a possible case scenario (Box 1), where a patient has suffered harm.


How is the standard of care determined in a new developing area of expertise?


The first question that arises in the case of Ben Morris is what standards of care should have been followed in using telemedicine to obtain a diagnosis? In new areas of expertise, where standards are still being developed, the law does not recognise a legal vacuum. If there were an allegation of negligence, expert evidence would be called on to provide information on the minimum standard of care that should be offered in any given situation. In Mr Morris's situation the following questions would be asked:


- Was there a duty of care?


- How would the standard of care be defined in accordance with the Bolam test (Box 2)? What would be considered to be reasonable competent professional practice?


- Was there any causal link between a breach of the reasonable standard of care expected and any harm that occurred?


The standard of care required in the use of telemedicine is determined in the civil courts. Under the Bolam test, the standards that should have been applied at the time of the incident are applied by the courts to the alleged negligence.


Are there any dangers in complete reliance on a video image?


If the consultant saw the patient face to face instead of giving his or her opinion at a distance, would other factors be taken into account in treatment and diagnosis?


The answer to this is 'probably', but it does not follow that an opinion given on an image at a distance would necessarily fall below the reasonable standard of care. There will of course be circumstances where a definitive opinion is withheld until there has been an actual physical examination of the patient. However, in recommending the new treatment, did the consultant take account of the relevant risk factors and ensure that sufficient information was obtained from Mr Morris?


Conclusions on standards of care


Telemedicine is a new development, so this means that, over the next few years, we can expect the General Medical Council, the royal colleges and the professional associations to publish standards of practice, procedures and protocols that will cover its use. It is possible, too, that telemedicine will come under scrutiny from the National Institute of Clinical Excellence and even, if things go wrong, from the Commission for Health Improvement or its successor body.


As these standards emerge and become supported by research into clinically effective practice, they will become merged within the Bolam test of approved acceptable practice.


Telemedicine applications and equipment should be subject to the same quality-assurance and risk-management processes as other areas of clinical practice. In his analysis of the management of clinical risk in telemedicine applications Darkins (1996) suggests that, although there are risks associated with the widespread introduction of telemedicine, these should be put in perspective, and a risk-management approach should be taken.


Accountability


Disputes may arise if, for example, a GP is present with a patient during a video conference with a consultant. The consultant may recommend that minor surgery is carried out by the GP under his televised supervision.


If the patient is harmed, who is liable? Both doctors are subject to the Bolam test in determining the extent to which the reasonable standard of care was followed. In determining liability, it will be a question of deciding, on the basis of the facts, whose negligence caused the harm. If, for example, the GP had failed to provide correct or sufficient information to the consultant about Mr Morris's history, medication and condition, as a result of which the consultant made an incorrect diagnosis, this could lead to the GP being held liable.


In view of this, Brahams (1995) points out that additional skills may be required for doctors practising from a distance using the aid of telecommunications.


Consent to telemedicine


There are two aspects of consent:


- The actual consent to what would otherwise be a trespass to the person (a term that includes both assault and battery);


- Negligence in the failure to fulfil the duty of care in informing the patient of the risks pertaining to the treatment.


Trespass to the person requires an actual or intended touching of the person. Therefore, with the use of telemedicine, there can be no trespass to the patient by the professional who is providing an opinion from a distance, whether via the radio, the internet or any other tele method. The professional does not touch the patient's body. This means that looking at a screen and commenting on it could not be actionable as a trespass to the person. However, there could be a trespass to the patient and action against the professional who was with the patient, if the patient's consent does not include their body being filmed or touched when pictures are obtained or examinations are carried out.


There is one significant difference between an action for trespass to the person and an action on the grounds of negligence. Action for trespass to the person is possible without proof of any harm. However, action for negligence is possible only in cases where there is proof that reasonably foreseeable harm resulted from the breach of the duty of care.


If telemedicine is used without a patient's consent there may be a breach of Article 8 of the European Convention on Human Rights and the right to respect for privacy.


Failure in the duty of care to inform


The law requires a patient to be informed of all the significant risks of substantial harm that could arise from the use of telemedicine according to the Bolam test. Information given to the patient should include risks of harm that might occur even if all reasonable care is taken. Consent does not include consent to the risk of practitioners being negligent. The patient's consent to the disclosure of information would also be required under the laws relating to confidentiality (see below).


Where the use of telemedicine is contemplated there are considerable advantages in ensuring that documentation for securing the patient's consent spells out exactly what is proposed and provides written information about any significant risks that may arise. The consent form is not the actual consent, but evidence that consent was given.


The consent forms recommended for use by the Department of Health (2001) could be adapted for use in telemedicine. The form should be accompanied by a verbal explanation of how the system will work, to ensure that the patient has reasonable information on which to base a valid consent. If there are doubts about the patient's mental competence to give a valid consent, an independent person could be asked to give an opinion on the patient's mental capacity.


In the case scenario presented here there is no evidence that Mr Morris did not give consent to the process of telemedicine, but there would be advantages in securing written evidence that consent has been given. It would also have been important to have recorded any risks of which that Mr Morris was informed before he agreed to the procedure. In addition, was he warned of any potential risks of the new treatment, and was agreement to have this treatment given in the light of these possible risks? If not, would he have agreed to continue with the treatment had he known of the risks?


Confidentiality and data protection


One of the most significant concerns about telemedicine is that the system must be secure, to prevent unauthorised access to the information. Security is necessary not only to meet the duty of confidentiality owed in respect of information obtained from the patient but also under the European Directive and the Data Protection Act 1998.


Article 8 of the European Convention of Human Rights recognises the right to respect for a person's private and family life. The convention is set out in Schedule 1 to The Human Rights Act 1998. It is vital that the system for telemedicine is robust in terms of passwords and level of access; that regular monitoring of its security takes place; and that all reasonable means are taken to prevent hackers gaining access to the data.


Article 1 of the European Directive requires member states to 'protect the fundamental rights and freedoms of natural persons and in particular their right to privacy with respect to the processing of personal data'.


Under the Human Rights Act 1998 it is an offence to transmit data to a third party without adequate levels of protection. Patients who consider that their rights have been breached are entitled to claim damages from the culprit. If, in the scenario set out in Box 1, the videotape of the telemedicine procedure had been used without Mr Morris's consent and shown to others without legal justification, this could be regarded as a breach of the patient's confidentiality and possibly of Article 8 of the Human Rights Act.


Rights of access


Exactly the same provisions apply to access to information transmitted through telemedicine as apply to the personal health records of the patient.


Under data protection legislation, the patient has a right of access to his or her personal records (manual and computerised), subject to specific exceptions. These exceptions are:


- Where serious harm would be caused to the physical or mental health or condition of the applicant or another person;


- Where a third person (not being a health professional caring for the patient) could be identified and has not agreed to be identified.


The telemedicine film would appear to be as much a part of the patient's records as computerised or manually held records.


Videotapes of telemedicine procedures that are retained could be accessed by patients under data protection legislation. Disputes could arise where videotapes have been edited, possibly to reduce the need for storage space. However, in cases where a videotape of the teleconsultation is retained it could be used in court to show on what information the consultant based his or her recommendations for diagnosis and treatment. It would also provide evidence of what was said by the patient and anyone else who was present.


Documentation Staff involved in using telemedicine should ensure that their records meet the guidelines set by the Nursing and Midwifery Council (2002).


Conclusion


The legal issues discussed in this article should not deter practitioners from exploiting the benefits of telemedicine. Rather, practitioners should be mindful of the problems that could occur and of potential claims from patients. Professionals should also ensure that their risk-management processes and their documentation robustly and realistically identify the potential risks involved.
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