Select Committee on Health Written Evidence


Memorandum by Dr Richard FitzGerald (PS 27)

MEDICAL REGULATION IN THE TELEMEDICINE ERA

EXECUTIVE SUMMARY:

  Medical regulation needs to be adapted to enable patients too safely and confidently access telemedicine.

  Telemedicine legislation is required in the UK.

  The medical revalidation procedures currently being developed by the General Medical Council and Medical Royal Colleges need to be suitable for those doctors who deliver care and diagnosis for British patients by telemedicine as well as those who deliver it in traditional face to face settings.

  EU action is also required.

PERSONAL INTEREST AND BACKGROUND

  I make this submission in a personal capacity and not on behalf of any other organisation. My interest is derived from my professional activities listed below:

    Consultant Radiologist, Royal Wolverhampton Hospitals NHS Trust, 1986-

    General Medical Council Radiologist Assessor, 2002-

    I have lectured on improving Radiological performance in the UK, Sweden, Denmark, Hungary, USA and was Visiting Professor of Radiology at the University of Western Australia in 2007.

    I have provided advice on teleradiology for the Royal College of Radiologists since 2004 and for the European Society of Radiology since 2006.

    UK Representative, Union of European Medical Specialists Section of Radiology 2001-

    Chairman, Royal College of Radiologist European Sub-committee 2007-

    Member, Union of European Medical Specialists Working Group on eHealth 2008-

    Member, Department of Health Teleradiology Project Group to advise on medical regulation 2007-

    Member, Royal College of Radiologists Standards Sub-committee, 2003-

  Publications on this topic:

    Medical Regulation in the Telemedicine Era. R. FitzGerald. Accepted for publication in The Lancet

    31st July 2008. The Lancet Reference D-08-05038R1

    Legal uncertainties linger as teleradiology expands. R FitzGerald. Diagnostic Imaging Europe August/ September 2008 pages 26-27 and 38-39

    Outsourcing and Teleradiology: Potential Benefits, Risks and Solutions from a UK/European Perspective. A.K. Dixon, R.FitzGerald. Journal of the American College of Radiology (2008) 5 : 12-18.

    Regulation and Revalidation of Teleradiologists. R. FitzGerald. Newsletter of the Royal College of Radiologists (2005) 81 : 15-16.

CURRENTS SCALE OF TELEMEDICINE AND IMPLICATIONS FOR PATIENT SAFETY:

  1.  The scale of existing eHealthcare/telemedicine delivery is under-recognised. Last December, the European Union's Information Society Directorate-General conference on telemedicine, had presentations about 2 million e-prescriptions in Sweden, telemonitoring of patients with cardiac problems leading to reduction in hospitalisations of 44%, teleophthalmology, teledermatology, telepathology, etc.http://ec.europa.eu/information_society/events/telehealth_2007

  2.  In England, waiting times for elective MRI scans have dramatically shortened because hundreds of thousands of patients have had their MRI scans reported through teleradiology. Many of these have been reported outside the UK.

  3.  In the USA 240,000 teleconsultations are conducted each year by the Department of Veterans Affairs and one provider of remote intensive care unit services has 150 client hospitals[161]

  4.  Telemedicine brings enormous benefits to many patients by virtue of improved access, timeliness, specialisation, cost effectiveness, quality and choice.

  5.  Power is shifting to patients, whose decisions on caregivers will not necessarily be well informed and whose healthcare providers may not be regulated. Microsoft's HealthVault and GoogleHealth are personally controlled health record products already available.[162]. Patients, or their chosen caregiver at a particular time, will be able to access virtual medical record repositories.

  6.  All healthcare poses risks to patients, whether traditional or through telemedicine. Limitation of practice for 9 months was imposed last year by the UK General Medical Council on a British doctor because of patient safety issues due to his e-prescribing. His referral to General Medical Council was made by 3 bona fide patients and 2 investigative journalists posing as patients. One journalist worked for The Independent on Sunday the other for The Sun. Sanction was only possible because the doctor practised within the UK.

  7.  A potential loop hole exists for surrogate interpretation of teleradiology images on a network by unlicensed individuals under the supervision of someone who does hold a licence. A single licensed Radiologist could theoretically front reporting by several others by signing off their reports.[163]

  8.  Malaysia passed a Telemedicine Act in 1997. 19 of the USA states require doctors practising telemedicine to have a special purpose license.[164]

  9.  In the UK, the recently published principles for the implementation of medical revalidation do not even mention the word telemedicine.[165]

  10.  There are no plans for the introduction of medical revalidation in any other EU member state. Indeed the UK will be the first country in the world to introduce a requirement for all the doctors caring for its citizens to revalidate/relicense.

  11.  A recent report from the EU Information Society Directorate-General states that European patients do not have the legal certainty and medical regulation they need as they increasingly access e-healthcare.[166] No EU legislation exists to require licensing of doctors who provide e-healthcare for EU patients from outside their state. Currently, the ease with which a doctor can register and practise on patients in another EU member state takes precedence over ensuring adequate medical regulatory safeguards for patient safety.

  12.  It is currently not clear which European Commission Directorate General, Health, Information Society or Internal Market will lead on regulation/legislation of telemedicine. The May 2008 Portoroz Declaration committed the European Union to a "paradigm shift towards clear support for eHealth". However it did not include a specific commitment on medical regulation.[167]

  13.  It will come as a surprise to many to learn that healthcare regulators across the EU do not universally inform each other when they restrict a practitioner's license to practice.[168] This is despite the strenuous efforts of the UK General Medical Council in the European partnership of healthcare regulators Healthcare Professionals Crossing Borders initiative.

  14.  Patient safety and trust require adaptation of medical regulation to the telemedicine era. Regulatory loopholes need to be closed. Telemedicine is a technology over 10 years old, whose application is increasing rapidly.

  15.  The standards of pioneer telemedicine providers may not be replicated by "cowboy" providers in the future. Increased competition may lead to costcutting with risks for patients. Patients and the public will neither understand nor forgive failure to adequately regulate. The media have already noted the hazards of e-prescribing.

  16.  UK legislation and regulation,while important, is inadequate for the global nature of telemedicine. Action also is required at EU level

RECOMMENDATIONS FOR ACTION:

  1.  UK legislation needs to be enacted to regulate telemedicine and telemedicine providers.

  2.  All doctors who care for and diagnose British patients by telemedicine from the UK or abroad need to be required by law to hold a license with the General Medical Council and be on its Specialist Register. Informal arrangements, recommendations, market forces are inadequate and inappropriate for patient safety.

  3.  All doctors who care for and diagnose British patients by telemedicine should subject to revalidation requirements like other British doctors of their specialty.

  4.  Telemedicine practitioners should be subject to the same regulations as other medical locums,

  5.  Telemedicine practitioners should be required to have individual medical insurance cover appropriate for the UK.

  6.  Telemedicine practitioners should be required to have an adequate knowledge of medical English as permitted by EU Qualifications Directive [ 2005], Article 53 of which states "persons benefiting from the recognition of professional qualifications shall have knowledge of languages necessary for practising the profession in the host member state".

  7.  Telemedicine practitioners should be required to be contactable by mobile phone for consultation with those healthcare professionals physically face to face with patients for whom they have provided ehealthcare.

  8.  Telemedicine providers who provide services for British patients should be regulated like medical locum agencies.

  9.  Telemedicine providers should be included in the current General Medical Council/Department of Health revalidation pilots eg on Responsible Officers who will "sign off" doctors as fit for revalidation/relicensure.

  10.  Medical Royal Colleges should be requested to include telemedicine practitioners in the current recertification pilots they are conducting in preparation for the introduction of revalidation in 2010.

  11.  Electronic fingerprinting, including verification of routing needs to be developed to prevent "ghosting" of teleradiology /telepathology reports, e-prescriptions etc.

  12.   There must be rapid introduction of compulsory automatic notification of all other EU member states' medical regulators when there is a restriction on the license to practice of an individual doctor. The current "informal" and "voluntary" arrangements of the Portugal Agreement are inadequate and unsafe.[169]

  13.  There must be speedy introduction of an EU- wide Health Professional Card with unique professional identification number and up to date information about individual registration. This should be publicly accessible through the internet.[170] [171][172]

September 2008








161   Singh S N, Wachter R M. Perspectives on Medical Outsourcing and Telemedicine-Rough Edges in a Flat World? N Engl J Med 2008; 358:1622-1627Back

162   Kidd M R. Personal electronic health records: MySpace or HealthSpace? BMJ 2008; 336:1029-1030. Back

163   Thrall J H. Globalisation of Health Care. Radiology 2008; 247:3-7. Back

164   Cwiek MA, Rafiq A, Qamar A, Tobey C, Merrell RC. Telemedicine licensure in the United States : the need for a cooperative regional approach. Telemedicine and e-Health 2007; 13 : 141-147 Back

165   Department of Health. Medical revalidation- principles and next steps: the Report of the Chief Medical Officer for England's Working Group. 23rd July 2008 Back

166   European Commission Information Society and Media Directorate General. Legally eHealth. Putting eHealth in its European Legal Context. Legal and regulatory aspects of eHealth. Study report March 2008. http://ec.europa.eu/information_society/activities/health/docs/studies/legally-ehealth-report.pdf Back

167   The European Commission and EU Member States. The Portoroz Declaration, 7 May 2008, eHealth 2008 Conference Declaration. eHealth in a Europe "without frontiers" : Building New Initiatives-Working Together. http://ec.europa.eu/information_society/newsroom/cf/itemdetail.cfm?item_id=4094 Back

168   Healthcare Professionals Crossing Borders-Portugal Agreement. An Agreement of the Healthcare Professionals Crossing Borders partnership made in Lisbon, Portugal on 8 October 2007. www.hpcb.eu Back

169   Healthcare Professionals Crossing Borders-Portugal Agreement. An Agreement of the Healthcare Professionals Crossing Borders partnership made in Lisbon, Portugal on 8 October 2007. www.hpcb.eu Back

170   Health and Consumer Protection Directorate-General, European Commission. Summary report of the responses to the consultation regarding "Community action on health services" (SEC (2006) 1195/4 of 26 September 2006) Back

171   European Society of Radiology. Submission of the response of the European Society of Radiology and the Union of European Medical Specialists Section of Radiology to the European Commission Community Action on Health Services Consultation, January 2007. http://ec.europa.eu/health/ph_overview/co_operation/mobility/docs/health_services_co88.pdf Back

172   International Radiology Quality Network. International Clinical Teleradiology Standards: Top ten principles of International Clinical Teleradiology 2007. http://www.irqn.net/content/standards.shtml£clinical Back


 
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