Medicolegal and regulatory aspects of whole slide imaging-based telepathology

Published:November 13, 2014DOI:https://doi.org/10.1016/j.mpdhp.2014.10.004

      Abstract

      Telepathology is lauded for its potential to overcome geographic barriers and bring expert diagnostic opinions to underserved regions. However, the legal and regulatory aspects governing its use in the United States and abroad are disparate and incomplete. In addition, there is essentially no case law that specifically addressed telepathology. Important issues to consider for the implementation and practice of telepathology, including state and regional licensure requirements, credentialing and privileging, liability and medical malpractice coverage, privacy and security, medical device regulation, and reimbursement for services are reviewed here for several regions, including the United States, Canada, the European Union, and China.

      Keywords

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      References

        • Evans A.J.
        • Kiehl T.R.
        • Croul S.
        Frequently asked questions concerning the use of whole-slide imaging telepathology for neuropathology frozen sections.
        Semin Diagn Pathol. 2010; 27: 160-166
        • Cornish T.C.
        • Swapp R.E.
        • Kaplan K.J.
        Whole-slide imaging: routine pathologic diagnosis.
        Adv Anat Pathol. 2012; 19: 152-159
        • Stanberry B.
        Legal and ethical aspects of telemedicine.
        J Telemed Telecare. 2006; 12: 166-175
        • Allen T.C.
        Intradepartmental consultation: what is the pathologist's legal liability?.
        Arch Pathol Lab Med. 2014; 138: 589-591
        • Sao D.
        • Gupta A.
        • Gantz D.A.
        Legal and regulatory barriers to telemedicine in the United States: public and private approaches toward health care reform.
        in: Cohen I.G. The globalization of health care: legal and ethical issues. Oxford University Press, Oxford2013: 359-379
        • Têtu B.
        • Evans A.
        Canadian licensure for the use of digital pathology for routine diagnoses: one more step toward a new era of pathology practice without borders.
        Arch Pathol Lab Med. 2014; 138: 302-304
        • Steinbrook R.
        Interstate medical licensure: major reform of licensing to encourage medical practice in multiple states.
        JAMA. 2014; 312: 695-696
        • Bierig J.
        Mr. Smith goes to Washington and the implications of his lawsuit there for the interstate practice of pathology.
        CAP Today, 2011 ([March])
        • Smith V.
        Laboratory Corporation of America, Inc., Case No. C09–1662-JCC, Western District of Washington.
        2010
        • Hiemenz M.C.
        • Leung S.T.
        • Park J.Y.
        Crossing boundaries: a comprehensive survey of medical licensing laws and guidelines regulating the interstate practice of pathology.
        Am J Surg Pathol. 2014; 38: e1-e5
        • Department of Health and Human Services
        Telemedicine services in hospitals and critical access hospitals.
        July, 2011 (Available at:) (Accessed 19 Oct 2014)
        • Bernard C.
        • Chandrakanth S.A.
        • Cornell I.S.
        • et al.
        Guidelines from the Canadian Association of Pathologists for establishing a telepathology service for anatomic pathology using whole-slide imaging. Canadian Association of Pathologists Telepathology Guidelines Committee.
        J Pathol Inform. 2014; 5: 15
        • Federation of Medical Regulatory Authorities of Canada
        FMRAC policy on telemedicine.
        June, 2010 (Available at:) (Accessed 14 Oct 2014)
        • Collège des médecins Du Québec
        Telemedicine.
        May, 2000 (Available at:) (Accessed 14 Oct 2014)
        • College of Physicians and Surgeons of New Brunswick
        Regulation #13: telemedicine.
        September, 2008 (Available at:) (Accessed 14 Oct 2014)
        • College of Physicians and Surgeons of Alberta
        Standard of practice: telemedicine.
        June 5, 2014 (Available at:) (Accessed 14 Oct 2014)
        • College of Physicians and Surgeons of Saskatchewan
        Policy: the practice of telemedicine.
        November, 2013 (Available at:) (Accessed 14 Oct 2014)
        • College of Physicians and Surgeons of Newfoundland and Labrador
        Telemedicine.
        (Available at:) (Accessed 14 Oct 2014)
      1. Commision staff working document on the applicability of the existing EU legal framework to telemedicine services. December, 2012 (Available at:) (Accessed 14 Oct 2014)
        • Pirvu D.
        • Snyder R.E.U.
        Way ahead of the game on telehealth.
        TechHealth Perspectives, March, 2013 (Available at:) (Accessed 14 Oct 2014)
        • Dierks C.
        Legal aspects of telepathology.
        Anal Cell Pathol. 2000; 21: 97-99
        • The National Health and Family Planning Commission of the People’s Republic of China
        The opinions of the National Health and Family Planning Commission regarding the promotion of the Medical Institution Telemedicine Services.
        August 29, 2014 (English translation by Foley & Lardner, LLP. Available at:) (Accessed 14 Oct 2014)
        • Dai D.
        • Qin M.
        • Yang M.
        China's NHFPC issues opinions on promotion and administration of telemedicine services.
        McDermott, Will and Emory, 2014 (Accessed 14 Oct 2014)
        • Van Moore A.B.
        • Campbell S.C.
        • Carlson R.A.
        • et al.
        Report of the ACR task force on international teleradiology.
        J Am Coll Radiol. 2005; 2: 121-125