How Technology is Shifting Agency from Doctors to Patients: The Cost and Impact of Medical Technologies to Traditional Liability and Malpractice.

• Author: Eikram, Iman

1. INTRODUCTION 609 II. BACKGROUND 610 A. Telemedicine 610 1. Licensure 611 2. Privacy 611 3. Malpractice 612 B. Home Diagnostic Tools 613 1. Instruments 615 2. Tests 616 3. Mobile Medical Apps 617 III. ANALYSIS 618 A. Licensing 619 B. Liability Concerns 619 1. Telemedicine 620 2. HDTs 622 IV. RECOMMENDATION 625 V. CONCLUSION 628 I. INTRODUCTION

   Modern medicine has long been the domain of physicians and been restricted to medical facilities. This is changing as technological advances have begun to alter conventional doctor-patient relationships and modern medicine. Recent innovations allow patients to remove hospitals from the process of diagnosis, and in increasingly common situations, even remove doctors. This Note examines how the application of new and old technologies in medicine affects the relationship of patients to the medical field, and the impact on liability. In Part II, this Note discusses the background of technological changes in the doctor-patient relationship by examining telemedicine and home diagnostic tools (HDTs). specifically, it discusses how medical tools have evolved and the different types of technology that reflect these changes. Part III analyzes how these changes alter current standards of liability. our understandings of liability law must adapt as technology redefines the actors and objects at the center of conventional liability suits. Finally, this Note will make recommendations to corporations regarding oversight and corporate responsibility in the manufacturing and distribution of new home medical technologies.

2. BACKGROUND

   To appreciate emerging liability issues with advancing medical technologies, one must first understand how those technologies are changing. There are two specific technologies this Note will address: telemedicine and Home Diagnostic Tools (HDTs). By examining these technologies, we can recognize why they are changing both products liability and the medical field.

   1. Telemedicine

      Telemedicine is the use of technology to enable the "practice[] [of] medicine at a distance." (1) The Food and Drug Administration (FDA) provides a more technical definition. They describe "'telemedicine' as the delivery and provision of health care and consultative services to individual patients and the transmission of information related to care, over distance, using telecommunication technologies, and incorporating [] direct clinical, preventive, diagnostic, and therapeutic services and treatment...." (2) Telemedicine was initially used in difficult circumstances, such as offering care in deep-sea mining ships or military endeavors. (3) Telemedicine has expanded to the public sphere due through innovation and increased access to technology. (4) Telemedicine provides information to patients in an environment they control. Currently, 71% of medical practitioners are using telemedicine, primarily for diagnosis and patient monitoring. It is especially common in smaller medical practices. (5) Telemedicine has the potential to save $6 billion in annual healthcare costs for employers. (6)

      The advantages of telemedicine are numerous, ranging from increased access of care to administrative ease. Telemedicine offers patients in remote areas increased access to health care and reduced cost of care. (7) It also offers better "utilization of specialist expertise, system coordination... and availability of patient records." (8) Because technology allows doctors to practice in remote areas, telemedicine creates a geographic displacement of health care while allowing professionals to "practice medicine in the normal manner." (9) This is because technology bridges the distance and allows doctors to collect and offer information without being physically present. Although some argue this increases the risk of mistakes and erodes the bond of trust between doctor and patient, there is little proof to substantiate these concerns. (10) Note, the term "medical professional" commonly includes vocations like midwives and physical therapists as well as licensed doctors. (11) That stated, this Note will primarily evaluate telemedicine practiced by licensed physicians. However, the same issues likely arise across all medical professionals, regardless of state categorization. Telemedicine faces three primary issues. The first is individual state licensing for permission to practice medicine in certain jurisdictions. The second is concerns of privacy when confidential information is moved to a new medium, thereby risking unauthorized access. The final issue concerns malpractice and what kind of liability is most appropriate in telemedicine.

      1. Licensure

         Medical licenses permit doctors to practice medicine in their licensing state. When doctors practice telemedicine they provide advice in the state they are licensed; but the advice is transmitted to a state in which they are not permitted to practice medicine. (12) Licensure is the first barrier to the growth of telemedicine. Medical licenses are the purview of states, with each state having its own criteria and requirements of practice. (13) This complicates matters when a doctor in State A provides medical services to a patient in State B without a license in State B via technological conduit. (14) Some states have hindered telemedicine by implementing laws that sanction interstate medical practice or define telemedical services as consultations. (15) Other states simply forbid the practice of medicine by out-of-state telepractitioners. (16) It can be difficult to determine where an injury has occurred when trying to file a malpractice claim in such cases. (17) Some argue that a suit must be filed in the state where the injury occurred, but it is also possible that the injury occurred in the state where the consultant is. (18) This is further complicated depending on what state licenses the doctor carries at the time of injury. (19)

      2. Privacy

         In an information age, privacy is fiercely defended. Telemedicine offers a flow of confidential information between parties, but many have criticized the lack of security of the transmission of information. Telemedicine information is regulated as confidential information by the Health Insurance Portability and Accountability Act (HIPAA) (21) but the risk of un-authorized access is intrinsic to telemedicine and cannot be legislated away. Ethical considerations and legal safeguards specifically protect medical information. (22) Any time information is conveyed to multiple parties it is vulnerable in some way. (23) This is not just the nature of telemedicine, but the nature of any industry that relies on technology. However, taking appropriate precautionary measures and exercising care mitigates this risk. (24) With the appropriate measures, the danger of data breach in telemedicine can be minimized. (25)

      3. Malpractice

         There is not a great deal of material regarding telemedicine malpractice suits, but the implications are no less important. The doctor-patient relationship is established when "the professional services of a physician are accepted by another person for the purposes of medical or surgical treatment." (26) Accordingly, there is a duty of care in telemedicine, which is not weakened by distance. (27) A medical malpractice case requires a plaintiff to establish negligence by proving: "(1) a duty by a physician to act according to certain standards; (2) a breach of this standard of care; (3) an injury; and (4) causation between the breach of care and the patient's injury." (28) Despite the level of removal from patients, the standard of care should be the same for telemedical doctors as it is for traditional doctors. (29) The issue of what state to hold someone liable in arises again in telemedicine malpractice suits. For instance, in which state should a practitioner purchase medical insurance? And in which state a practitioner is required to appear in a malpractice suit?

         These are some of the primary issues that prevent telemedicine from becoming fully realized as a medical tool. Disjointed policies across multiple states limit the national reach of telemedicine. Telemedicine has moved from an exclusively diagnostic tool to a clinical tool as well. (30) It has expanded into several smaller fields like telesurgery and teletrauma care, but all of them are limited by the above issues. Telemedicine is beginning to evolve in other ways; innovations in medical technology are beginning to re-shape the definition of tele-healthcare, which are discussed below.

   2. Home Diagnostic Tools

      Technology has started advancing in a way that renders some of the traditional uses of telemedicine obsolete. Conventional telemedicine reflects a change in access to patients by eliminating the need for proximity, but technology is slowly eliminating the reliance on medical professionals for diagnoses as well. (31) New technology gives patients previously inconceivable access and control over their medical care. These innovations are pushing conventional telemedicine into something less recognizable. The advent of Home Diagnostic Tools (HDTs) is one example of this phenomenon. These tools offer patients the ability to diagnose themselves with a multitude of medical conditions by making a simple purchase, without any input from a doctor. (32) At-home HIV testing kits represent one specific example. In 1997, the FDA considered home specimen collection kits used for HIV testing to be a form of telemedicine. (33) Users collected samples in their own homes, then submitted them to a central laboratory for testing. (34) The results were only available via phone, thus meeting the conventional understanding of telemedicine. (35) Less than 1% of HIV testing was conducted with home collection kits at the time and kits were not always readily available. (36) Now, HIV self-testing kits can be bought from Walmart for $40, and provides results in 20 minutes. (37) The significant change here is that the user does not need to contact...