Health Care Reform and Telemedicine: Promise and Peril
The Food and Drug Administration recently approved the use of RP-VITA, a robot doctor that can be used in a variety of clinical settings. RP-VITA is created by the same company that made the Roomba, iRobot.
This year the South Florida Hospital and Healthcare Association’s Annual Summit is addressing the question of “Competing Priorities? Community Health vs. Provider Health.” One of the Summit’s sessions focuses on “Telemetry, Telemedicine & Telehealth.” This topic reflects the recognition that the adoption of digital devices and communications in the delivery of health care items and services is a growing fact of the professional lives of physicians and other health care practitioners.
The success of Accountable Care Organizations (ACOs), bundled payment initiatives, patient-centered medical homes and other innovative health care delivery and financing models will depend on a number of factors. (Both participate in the Medicare Program’s Shared Savings Program and those established by private parties.) Clearly, participating physicians and other providers will need to find ways to control the cost of delivering health care items and services. They also will need to improve both the quality of care received by individuals and patient populations, all the while maintaining each individual patient’s satisfaction with the items and services he or she receives.
Many observers have pointed to telemedicine, the delivery of diagnostic and therapeutic medical services and patient care information through the use of electronic communications, as an important factor in achieving these goals. Telemedicine is not new. For example, hospitals have employed telemetry systems to monitor the health status of inpatients. “Nighthawk” services have provided remote reading and interpretation of radiology studies for a number of years. Physicians have used Holter monitors and similar devices to diagnose and treat patients on an outpatient basis. Electronic health records, patient-oriented web sites and regional health information organizations are all forms of telemedicine technology that already have been widely adopted by the health care delivery system.
The increasing interest in and adoption of telemedicine is the result of a combination of factors. Most significant are the technological advances which have enabled the development of more sophisticated telemedicine devices, such as the RP-VITA. While they do not replace the need for supervision and judgment provided by a physician or other licensed health professional, these devices make it possible to monitor and treat patients without the need for today’s level of traditional “hands-on” care. Second, the changing reimbursement scheme, which diminishes the importance of fee-for-service medicine for greater outcome accountability, means that health care providers need to find ways to reduce the resources needed to provide the same level of health care services. Another factor is the need to provide appropriate care to an aging patient population as efficiently and effectively as possible. The fourth factor is the increasing trend favoring the provision of care in the least intensive setting possible. This trend calls for the development of facilitating technologies.
Providers who are involved with ACOs, patient-centered medical homes and similar health care delivery models are becoming increasingly interested in exploring the adoption of telemedicine as part of their practices. As they do so, however, there are a number of questions that need to be answered. For example:
1. What specific licensures and certifications are needed to provide telemedicine in a patient’s home?
Most telemedicine devices are regulated by the Food and Drug Administration. Thus, as an initial matter, many telemedicine devices must first be approved by this agency before they may be used to diagnose or treat patients.
While telemedicine provides the technological ability to render services with little, if any, regard to the location of the patient or their physician, as with many areas of technological advancement, the law does not yet reflect that ability. In Florida, and in most other states, in order to provide health care items and services to a patient located here, the rendering physician or health care professional must be licensed in Florida. Despite the development of technology such as telemedicine services, that arguably may eliminate the need for a face-to-face patient encounter, a physician may not p rov i d e m e d i c a l s e r v i c e s v i a telemedicine unless he/she or a member of that physician’s group has already physically seen the patient.
2. What is the information that telemedicine is providing caregivers, etc.?
Telemedicine provides caregivers with information regarding the current medical status of patients. As such, this information is “protected health information” (“PHI”), as that term is used by HIPAA-HITECH. Thus, precautions must be taken in order to protect the security and privacy of patients’ PHI and ensure that those who have access to that PHI do so only to the “minimum necessary” PHI.
3. How should the information provided by telemedicine devices be handled?
Like other protected health information, data transmitted through the use of telemedicine needs to be treated in a manner that complies with HIPAAHITECH in order to ensure that it is accessed only by authorized covered entities and their Business Associates.
Telemedicine raises many of the issues inherent in the use of mobile devices. While not required by HIPAA, encryption of data transmitted through telemedicine is a prudent measure to ensure that patients’ PHI is not intercepted and used by parties who are not authorized to do so. Remember, under HIPAA-HITECH an unauthorized disclosure of PHI that is not encrypted is deemed to be a breach and the covered entity and Business Associate(s) with access to that information may be subject to civil or criminal sanctions, as well as find themselves defending a lawsuit filed by a aggrieved patient.
The use of telemedicine also raises a question as to whether a vendor needs to be a party to a Business Associate Agreement. If the equipment stores PHI that is accessible by a vendor who is responsible for maintaining it, then a Business Associate Agreement may be appropriate. That also may be the case if telemedicine equipment is stored at a third party location.
4. What is the potential liability associated with using telemedicine to provide care to patients in their homes?
One of the untested question involves liability when telemedicine equipment malfunctions, provides inaccurate data or otherwise does not live up to expectations. Like the interception and misuse of unencrypted PHI, power failures and equipment malfunctions are foreseeable. Thus, as reliance on telemedicine increases, it will become increasingly incumbent on health care providers to ensure that this equipment is designed with redundant systems and carefully maintained in accordance with manufacturers’ schedules.
Telemedicine no longer is limited to reading radiological studies off-site or monitoring the status of patients in hospital step-down units. Telemedicine technology is rapidly altering the way in which health care diagnostic and therapeutic services are rendered, without regard to a patient’s location. It was not long ago that the RP-VITA, like Dick Tracy’s wristwatch telephone, were elements of science fiction. Over time, it seems very likely that more and more of medical diagnostic, monitoring and therapeutic services will be provided through telemedicine devices.
Stephen H. Siegel is Of Counsel with the Miami office of Broad and Cassel and a member of the statewide firm’s Health Law Practice Group. The Board Certified Health Lawyer has been practicing law for more than 25 years and focuses his practice in all areas of health law, ranging from regulatory issues to enforcement and general corporate matters. He can be reached at 305.373.9400 or shsiegel@broadandcassel.com.
