Telemedicine, sometimes referred to as telehealth, is, in brief, the remote diagnosis, care and treatment of a patient by using technologies. There are many definitions of telemedicine. The interpretation of telemedicine adopted by the World Health Organization in its policies on health telematics is: “the delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities.” A more liberal interpretation of telemedicine includes doctor-to-doctor and generalist-to-specialist interactions. The discussion in this article primarily covers doctor-to-patient telemedicine.
Biometric technologies and healthcare analytics are being developed to allow diagnosis and treatment (for example, prescription of medicine) via telephone or internet-based medical consultations between patients and their medical doctors. Increasing amounts of investment from venture capitalists in the life sciences industry are being directed into digital healthcare.
Advantages of telemedicine include cost-effectiveness, access to specialty and sub-specialty medical care, access to medical care for patients in rural or underserved areas, and the use of advanced telecommunications technologies to provide continuous or periodic clinical assessment and monitoring of remote patients. One example of government-sanctioned use of telemedicine is from the United States department of health and human Services, which allows a hospital to share neuro emergency telemedicine resources with another hospital, in the interest of improving medical care for stroke patients by reducing unnecessary patient transfers and, correspondingly, decreasing the costs associated with these transfers, such as ambulance services. The timely treatment of stroke patients also decreases the incidence of stroke-related disabilities, which, in turn, decreases the costs associated with treating and supporting such patients. details can be found in the United States Office of Inspector General Advisory Opinion no. 11-12.
“Telemedicine is an open and constantly evolving science, as it incorporates new advancements in communication technology and responds to the changing health needs of aging, widely disbursed and time-deprived societies.”
As such, telemedicine providers face many commercial and compliance challenges. On the commercial side, before health services providers can encourage patients to explore telemedicine, they must first deal with the issues of insurance coverage and reimbursements. One legislative solution is to have parity laws that require national and private health insurers to cover and provide reimbursement for services provided via telemedicine in a comparable manner to how the health insurers would for the equivalent services provided in an in-person consultation or examination.
On the compliance side, telemedicine is sufficiently different from usual care as to require its own medical practice protocols, which govern matters such as training, technology, standards of care, professional liability, maintenance of medical records, insurance coverage, informed consent, disclosures, continuity of care, and bona fide doctor-patient relationship. In countries where telemedicine is more developed, there are laws and regulations that set minimum standards of practice for medical care provided via electronic means, such as the online prescription of medications.
CYBERSECURITY IMPLICATIONS OF TELEMEDICINE
Telemedicine requires individually identifiable information, in the form of audio files, clinical data, digital images and videos, to be captured and stored online and offline in multiple databases and devices. Therefore, in addition to medical laws and regulations, sharing medical information via technology comes with significant telecommunication, cybersecurity and personal data privacy implications. From an information technology law perspective, implementation of telemedicine will require:
- patient privacy protocols that:
- are compliant with data protection laws in multiple jurisdictions; and
- include guidelines on data disclosures and the sharing of data and management responsibilities with other health care providers and telemedicine service providers.
- data storage, processing and transmission security protocols for protecting health information from unauthorized access by unauthorized persons;
- personnel training for the proper storage, processing and transmission of medical data of individuals;
- compliance programs for using internet-based platforms to deliver medical care;
- incorporation of telemedicine-specific risks into any existing compliance programs; and
- guidelines on what data are to be maintained as part of the medical record of patients.
TELEMEDICINE IN JAPAN
The telemedicine industry in Japan is much less established than that in the United States. Unlike the United States, Japan does not yet have any legislation that specifically regulates telemedicine. On licensure for medical practice, only medical doctors who are licensed in Japan can legally practise medicine in Japan, which essentially prevents overseas telemedicine providers to operate in the Japanese market without Japan-licensed medical doctors on staff.
Article 20 of the Japan medical Practitioners’ Act stipulates that no medical practitioner is to provide medical care or issue any medical certificate or prescription without personally performing an examination. however, a notice issued by the Japan ministry of health, Labor and Welfare clarifies that telemedicine is permitted for the remote medical treatment of certain stay-at-home patients, such as those receiving oxygen therapy and those suffering from incurable disease, diabetes, asthma, high blood pressure, atopic dermatitis, decubitus ulcer, cerebrovascular disorder, or cancer. For these patients, telemedicine can only be provided:
- if face-to-face consultation between the patient and his or her medical doctor is impossible; or
- if it is used for the treatment of a chronic disorder suffered by a patient who is in a stable condition.
Much like regulations in other countries, neither diagnosis nor treatment can be provided through telemedicine in Japan without an initial physical examination conducted by a medical doctor licensed in Japan.
TELEMEDICINE IN CHINA
On 29 August 2014, the chinese national health and Family Planning commission (cnhFPc) issued the Opinions of the national health and Family Planning commission Regarding Promoting healthcare Institutions’ Telemedicine Services (circilar51) and the cnhFPcinterpretations of circular 51, which are china’s first comprehensive guidelines on telemedicine. This demonstrates the chinese government’s efforts in promoting the development of telemedicine services under enhanced supervision by regulatory authorities.
Circular 51 defines the scope of telemedicine services as the use of information technologies:
- where one healthcare institution invites another healthcare institution to use communication, computer and network technologies to provide technical support in the diagnosis and treatment of its patients; or
- where a healthcare institution provides medical services directly to its offsite patients.
Circular 51 provides a comprehensive framework regarding requirements imposed on healthcare institutions that provide telemedicine services and regarding the implementation of telemedicine practices. contrary to expectations, circular 51 does not exclude foreign healthcare institutions from being eligible telemedicine services providers in china. In fact, it is specifically provided that circular 51 applies to telemedicine services between chinese and foreign healthcare institutions.
Individual healthcare practitioners cannot provide telemedicine services to patients on their own. circular 51 stipulates that if healthcare practitioners wish to provide telemedicine services directly to patients outside their own healthcare institutions, they must obtain consent form the healthcare institutions where they are registered to practise, and they must use the medical data platforms established by their healthcare institutions to provide diagnostic and treatment services to their telemedicine patients.
If a healthcare institution is to provide telemedicine services, it must have appropriate equipment and qualified medical professionals to facilitate its operations of telemedicine services. It must ensure that telemedicine service information systems are compliant with medical and data security laws and regulations. This includes designating dedicated departments or persons to run regular tests on the equipment, and where appropriate, to arrange for suitable modifications and updates.
Healthcare institutions are required to suspend telemedicine services and to file reports with local regulatory authorities:
- if there are any changes to their professional technical staff, key equipment or facilities, or any other conditions that result in it becoming unable to properly provide telemedicine services;
- if there are any issues with the safety or quality of telemedicine services; or
- if any telemedicine-related adverse event happens.
On 15 January 2015, the cnhFPc officially announced the publication of the Telemedicine Information System construction Technical Guide, which presents a broad proposal for building a uniform national telemedicine services network in china. In anticipation of this infrastructure development, foreign life sciences companies and medical care professionals who wish to take part in the chinese digital healthcare market should consider the compatibility and suitability of their products and services to improve investment opportunities and chances of successful ventures.
Telemedicine is one development that can help improve the quality of medical services and provide better access to medical care for people living in remote areas around the world.
However, telemedicine presents complex legal issues. This is particularly true since technology eliminates the need to have face-to-face examination or medical consultation in a single geographic place, which was the historic assumption behind the licensing of medical providers and the regulation of medical services previous to advancements in the art of communications through technology. Technology now permits us to cross through geographic and legal barriers with ease. To name just two legal challenges to resolve, regulators must consider:
- whether cross-border telemedicine will be governed by the laws and regulations of;
- the place of residence of the patient who is receiving care and treatment; or
- the jurisdiction in which the medical care provider is licensed; and
- how the laws of the jurisdiction of the patient and the jurisdiction of the medical care provider can be harmonized to permit telemedicine and regulate the rights and duties of both the patient and the medical care provider.
It is not surprising that implementation of laws lags behind technological advancements. In a critically important area such as healthcare, there is a need to pick up the pace.