Cardiovascular Revascularization Medicine 15 (2014) 261–262
Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Editorial
Telemedicine is here but…
During the last decade, there has been an ongoing transformation in healthcare services using telemedicine, also known as telehealth. Telemedicine is the use of medical information via electronic communication to improve patients’ health status. The term “telehealth” applies to remote healthcare communication, which does not always involve clinical services. Telemedicine emerged as a legitimate source of healthcare information to provide an ever-growing number of services, including health education. Initially, telemedicine was limited to phone, facsimile, and video conferencing, but with advances in technology, smart phones, tablets, apps, and high-speed internet enable patients and providers to connect and conference for consultations, diagnoses, second opinions, disease treatment, health monitoring, and medical education for a variety of health conditions. There are two main types of telemedicine—interactive and asynchronous. Interactive telemedicine uses audio and video realtime teleconferencing, which connects a live healthcare provider and a patient in a two-way communication and allows them to share imaging and documents. Asynchronous telemedicine, also known as “store and forward,” records medical information, such as audio, movie clips, or still images (store) and transmits (forward) the information to a remote site at a later time. Telemedicine in each of these forms has the potential to improve patient care in remote areas. It can also connect healthcare professionals with people in their homes for remote monitoring and telehome care. In doing so, patients with chronic diseases can be monitored on a daily basis and can avoid frequent office visits. These features can improve patient compliance, and they have the potential to reduce costs and readmission rates. In the current issue of CRM, our group details a study that used a smart phone app to allow interventional cardiologists, referring physicians, and other healthcare personnel to communicate about patients presenting with chest pain, who are diagnosed in the field with ST segment elevation myocardial infarction (STEMI) and are candidates to be triaged directly to the catheterization laboratory for primary percutaneous coronary intervention. This real-time, two-way interaction among healthcare specialists in different locations resulted in improved diagnosis of STEMI by expert interventional cardiologists, expedited the patient transfer to the catheterization laboratory, and shortened the door-to-balloon time when compared to the conventional communication. As demonstrated in the study, through telemedicine, healthcare personnel have the ability to transfer and share images from a variety of technologies, including electrocardiogram, angiography, computed tomography, echocardiography, magnetic resonance imaging, and microscopic pathology findings, with sufficient quality and speed from anywhere in the world as long as there is an internet connection. Experts can diagnose a rare disease of a patient who is located in any part of the globe in a matter of minutes. The broad use of http://dx.doi.org/10.1016/j.carrev.2014.08.001 1553-8389/© 2014 Published by Elsevier Inc.
telemedicine is beyond imagination. With existing applications, a simple hearing tool, and a phone camera, a mother can take photographs of her child’s ears and transmit the photos to a specialist, who is located in a tertiary center thousands of miles away. The physician will make a diagnosis, for example, otitis media, and then ship antibiotics overnight that will potentially save the hearing of a child who does not have access to healthcare providers on a rural site. Furthermore, patients can check their blood sugar, blood pressure, oxygen saturation, and heart rate twenty-four hours a day, seven days a week with their smart phones, and they can get immediate feedback on their treatment strategy. Patients can set reminders on their tablets and smart phones to take their drugs, monitor their food calories by taking a photo of the food that they are about to eat, and monitor their daily exercise. Telemedicine technology can be integrated with large databases of electronic medical records and used as an integral part of research by providing outcomes of millions of patients with respect to the use of new and existing drugs and medical devices. The delivery of healthcare via telemedicine is here and is already transforming the global healthcare landscape. Currently, telemedicine is being adopted by several nations that are using the technology to close the gap in healthcare while lowering the cost of treating patients. The growth and widespread use of telemedicine continues to increase. According to a report from BCC research, the global telemedicine market is estimated to grow to $27.3 billion and the telehospital/clinic market segment to $17.6 billion dollars in 2016. This explosion of telemedicine and its dissemination poses a challenge to the federal healthcare agencies. Telemedicine market growth has been driven also by the implementation of the Patient Protection and Affordable Care Act, a two-year-old law that has intensified the focus on telemedicine as a way to treat an increasing number of people who will be seeking health insurance and medical services. Telemedicine technology enables healthcare personnel to meet this increasing demand, with a reduced cost and without delays in treatment. Both the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have reacted and responded to the telemedicine frenzy with respect to the regulatory and the reimbursement aspects of the technology for day-to-day healthcare. The FDA regulates the safety and effectiveness of telemedicine medical devices and software via the Center for Devices and Radiological Health. The center is responsible for ensuring the safety and effectiveness of the medical devices used in telemedicine systems. The center’s principle areas of responsibility are premarket review, postmarket surveillance, quality systems, standards, and science relating to telemedicine. The FDA requires registration and listing, premarket notification and/or approval, good manufacturing practices, and postmarket surveillance. The FDA also regulates the software used in telehealth
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Editorial
systems. In February 2011, the FDA announced the Medical Device Data Systems (MDDS) Final Rule, which defines an MDDS as a device through which medical data are passively communicated. As an FDA Class I device, an MDDS is not intended to be used for active patient monitoring. In contrast, devices that transmit medical data that are used by healthcare professionals to make immediate decisions and take clinical action are regulated at a higher level (Class II or Class III). The MDDS Final Rule is published in the Code of Federal Regulations 21 Part 880, Docket No. FDA-2008-N-0106, and the FDA has devoted resources to oversee these important issues. CMS is also moving to adapt aspects of the technology and to implement a reimbursement program and incentives for the use of telemedicine. CMS defines telehealth (or telemonitoring) as “the use of telecommunications and information technology to provide access to health assessment, diagnosis, intervention, consultation, supervision and information across distance.” For example, the Center for Medicare and Medicaid Innovation (the Innovation Center) has been directed to test new models of care using telemedicine to improve the care of hospitalized patients, including those in intensive care, through electronic monitoring by specialists located at other facilities. The Innovation Center is developing new care models that use patient-based remote monitoring systems to coordinate care over time and across settings. In addition, accountable care organizations are required to create ways to promote evidence-based medicine and patient engagement, report on quality and cost measures, and coordinate care. Although telemedicine is accepted with great enthusiasm, there are drawbacks of the technology that affect the patient, the provider, health organizations, and the technology developers. Patients miss the personal connection with the physicians and may feel a sense of insecurity and lack of trust using the telemedicine technology. The technology is not suitable for all ages, cultures, and levels of education. Users may be intimidated by the technology and have challenges operating the system. In addition, patients may be uncertain of their medical privacy. Physicians who lack hands-on and face-to-face interactions with their patients may give an incomplete diagnosis, and for the elderly and patients with dementia, the consultation is
potentially further complicated because their sensory impairment makes it much more difficult for the physicians. Healthcare organizations are confronted with the cost and responsibility of implementing the technology and are liable for its functioning, which could be challenging in rural areas with limited technical support. The organizations are required to develop telemedicine-specific policies and procedures and are liable for the security and privacy of medical information and for the providers and organizations with which they are affiliated. Technology developers depend on reliable sources of electrical stability and a robust internet connection, and they must secure their systems to prevent software violations, glitches, hacking, and above all to protect patient privacy. Finally, healthcare professionals who use telemedicine must meet the standards of evidence-based medicine and patient engagement, report on quality and cost measures, and coordinate care. This can be achieved by well-conducted (and costly) studies. Telemedicine is the future of healthcare, but before a full transformation occurs, many issues still need to be addressed to make the safe, accurate, and effective transition for the benefit of all healthcare professionals and patients. Ron Waksman Editor in Chief Sources: 1. Global Markets for Telemedicine Technologies, October 2013, Report Code: HLC014F. 2. Harper J, Pros and Cons of Telemedicine for Today's Workers, US News and World Report, July 24, 2012. 3. American Telemedicine Association, What is Telemedicine? Available online at www.americantelemed.org/i4a/pages/index. cfm?pageid=3333. 4. Centers for Medicare and Medicaid Services, Telemedicine and Telehealth, Available online at http://www.cms.gov/Medicare/MedicareGeneral-Information/Telehealth/index.html. 5. Epstein Becker Green, FDA Regulation of Mobile Health Technologies, June 2012.
Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Editorial
Telemedicine is here but…
During the last decade, there has been an ongoing transformation in healthcare services using telemedicine, also known as telehealth. Telemedicine is the use of medical information via electronic communication to improve patients’ health status. The term “telehealth” applies to remote healthcare communication, which does not always involve clinical services. Telemedicine emerged as a legitimate source of healthcare information to provide an ever-growing number of services, including health education. Initially, telemedicine was limited to phone, facsimile, and video conferencing, but with advances in technology, smart phones, tablets, apps, and high-speed internet enable patients and providers to connect and conference for consultations, diagnoses, second opinions, disease treatment, health monitoring, and medical education for a variety of health conditions. There are two main types of telemedicine—interactive and asynchronous. Interactive telemedicine uses audio and video realtime teleconferencing, which connects a live healthcare provider and a patient in a two-way communication and allows them to share imaging and documents. Asynchronous telemedicine, also known as “store and forward,” records medical information, such as audio, movie clips, or still images (store) and transmits (forward) the information to a remote site at a later time. Telemedicine in each of these forms has the potential to improve patient care in remote areas. It can also connect healthcare professionals with people in their homes for remote monitoring and telehome care. In doing so, patients with chronic diseases can be monitored on a daily basis and can avoid frequent office visits. These features can improve patient compliance, and they have the potential to reduce costs and readmission rates. In the current issue of CRM, our group details a study that used a smart phone app to allow interventional cardiologists, referring physicians, and other healthcare personnel to communicate about patients presenting with chest pain, who are diagnosed in the field with ST segment elevation myocardial infarction (STEMI) and are candidates to be triaged directly to the catheterization laboratory for primary percutaneous coronary intervention. This real-time, two-way interaction among healthcare specialists in different locations resulted in improved diagnosis of STEMI by expert interventional cardiologists, expedited the patient transfer to the catheterization laboratory, and shortened the door-to-balloon time when compared to the conventional communication. As demonstrated in the study, through telemedicine, healthcare personnel have the ability to transfer and share images from a variety of technologies, including electrocardiogram, angiography, computed tomography, echocardiography, magnetic resonance imaging, and microscopic pathology findings, with sufficient quality and speed from anywhere in the world as long as there is an internet connection. Experts can diagnose a rare disease of a patient who is located in any part of the globe in a matter of minutes. The broad use of http://dx.doi.org/10.1016/j.carrev.2014.08.001 1553-8389/© 2014 Published by Elsevier Inc.
telemedicine is beyond imagination. With existing applications, a simple hearing tool, and a phone camera, a mother can take photographs of her child’s ears and transmit the photos to a specialist, who is located in a tertiary center thousands of miles away. The physician will make a diagnosis, for example, otitis media, and then ship antibiotics overnight that will potentially save the hearing of a child who does not have access to healthcare providers on a rural site. Furthermore, patients can check their blood sugar, blood pressure, oxygen saturation, and heart rate twenty-four hours a day, seven days a week with their smart phones, and they can get immediate feedback on their treatment strategy. Patients can set reminders on their tablets and smart phones to take their drugs, monitor their food calories by taking a photo of the food that they are about to eat, and monitor their daily exercise. Telemedicine technology can be integrated with large databases of electronic medical records and used as an integral part of research by providing outcomes of millions of patients with respect to the use of new and existing drugs and medical devices. The delivery of healthcare via telemedicine is here and is already transforming the global healthcare landscape. Currently, telemedicine is being adopted by several nations that are using the technology to close the gap in healthcare while lowering the cost of treating patients. The growth and widespread use of telemedicine continues to increase. According to a report from BCC research, the global telemedicine market is estimated to grow to $27.3 billion and the telehospital/clinic market segment to $17.6 billion dollars in 2016. This explosion of telemedicine and its dissemination poses a challenge to the federal healthcare agencies. Telemedicine market growth has been driven also by the implementation of the Patient Protection and Affordable Care Act, a two-year-old law that has intensified the focus on telemedicine as a way to treat an increasing number of people who will be seeking health insurance and medical services. Telemedicine technology enables healthcare personnel to meet this increasing demand, with a reduced cost and without delays in treatment. Both the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have reacted and responded to the telemedicine frenzy with respect to the regulatory and the reimbursement aspects of the technology for day-to-day healthcare. The FDA regulates the safety and effectiveness of telemedicine medical devices and software via the Center for Devices and Radiological Health. The center is responsible for ensuring the safety and effectiveness of the medical devices used in telemedicine systems. The center’s principle areas of responsibility are premarket review, postmarket surveillance, quality systems, standards, and science relating to telemedicine. The FDA requires registration and listing, premarket notification and/or approval, good manufacturing practices, and postmarket surveillance. The FDA also regulates the software used in telehealth
262
Editorial
systems. In February 2011, the FDA announced the Medical Device Data Systems (MDDS) Final Rule, which defines an MDDS as a device through which medical data are passively communicated. As an FDA Class I device, an MDDS is not intended to be used for active patient monitoring. In contrast, devices that transmit medical data that are used by healthcare professionals to make immediate decisions and take clinical action are regulated at a higher level (Class II or Class III). The MDDS Final Rule is published in the Code of Federal Regulations 21 Part 880, Docket No. FDA-2008-N-0106, and the FDA has devoted resources to oversee these important issues. CMS is also moving to adapt aspects of the technology and to implement a reimbursement program and incentives for the use of telemedicine. CMS defines telehealth (or telemonitoring) as “the use of telecommunications and information technology to provide access to health assessment, diagnosis, intervention, consultation, supervision and information across distance.” For example, the Center for Medicare and Medicaid Innovation (the Innovation Center) has been directed to test new models of care using telemedicine to improve the care of hospitalized patients, including those in intensive care, through electronic monitoring by specialists located at other facilities. The Innovation Center is developing new care models that use patient-based remote monitoring systems to coordinate care over time and across settings. In addition, accountable care organizations are required to create ways to promote evidence-based medicine and patient engagement, report on quality and cost measures, and coordinate care. Although telemedicine is accepted with great enthusiasm, there are drawbacks of the technology that affect the patient, the provider, health organizations, and the technology developers. Patients miss the personal connection with the physicians and may feel a sense of insecurity and lack of trust using the telemedicine technology. The technology is not suitable for all ages, cultures, and levels of education. Users may be intimidated by the technology and have challenges operating the system. In addition, patients may be uncertain of their medical privacy. Physicians who lack hands-on and face-to-face interactions with their patients may give an incomplete diagnosis, and for the elderly and patients with dementia, the consultation is
potentially further complicated because their sensory impairment makes it much more difficult for the physicians. Healthcare organizations are confronted with the cost and responsibility of implementing the technology and are liable for its functioning, which could be challenging in rural areas with limited technical support. The organizations are required to develop telemedicine-specific policies and procedures and are liable for the security and privacy of medical information and for the providers and organizations with which they are affiliated. Technology developers depend on reliable sources of electrical stability and a robust internet connection, and they must secure their systems to prevent software violations, glitches, hacking, and above all to protect patient privacy. Finally, healthcare professionals who use telemedicine must meet the standards of evidence-based medicine and patient engagement, report on quality and cost measures, and coordinate care. This can be achieved by well-conducted (and costly) studies. Telemedicine is the future of healthcare, but before a full transformation occurs, many issues still need to be addressed to make the safe, accurate, and effective transition for the benefit of all healthcare professionals and patients. Ron Waksman Editor in Chief Sources: 1. Global Markets for Telemedicine Technologies, October 2013, Report Code: HLC014F. 2. Harper J, Pros and Cons of Telemedicine for Today's Workers, US News and World Report, July 24, 2012. 3. American Telemedicine Association, What is Telemedicine? Available online at www.americantelemed.org/i4a/pages/index. cfm?pageid=3333. 4. Centers for Medicare and Medicaid Services, Telemedicine and Telehealth, Available online at http://www.cms.gov/Medicare/MedicareGeneral-Information/Telehealth/index.html. 5. Epstein Becker Green, FDA Regulation of Mobile Health Technologies, June 2012.
