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Senior Associate, Goltsblat BLP*, Competition & Antitrust / Healthcare & Pharmaceuticals
The last few years have seen a boom
in remote diagnostics and healthcare
solutions. Major manufacturers of both
dedicated medical equipment and consumer
electronics are flooding the market with more
and more sophisticated gadgets for patients to
monitor all their vitals in real time, transmit this
information to doctors and receive the prompt
advice they need.
Yet this sector is just the tip of the
“telemedicine technologies” iceberg, though
the average consumer does not always
understand what this means. “Telemedicine” is
most generally understood as a set of technical,
legal and other arrangements for providing
patients with medical help based on procedures,
methods and options for transmitting data
ensuring that medical staff, patients and other
healthcare parties are identified correctly.
Regulating Telemedicine in Russia
So far, distant healthcare is not expressly covered by Federal Law No. 323-FZ of November 21, 2011, “On the Fundamentals of Public Healthcare in the Russian Federation.” Patients may get medical advice or prescriptions only by visiting or calling a doctor, which overburdens healthcare workers. For instance, a therapist’s standard time per patient at treatment and preventive facilities is 15 minutes — not because this is enough for a diagnosis but because of the “high traffic” and the need to see as many patients as possible. Telemedicine technologies could lift this burden from both GPs and specialists treating the same patients on a regular basis.
Until now, practical work under regional healthcare IT support programmes has consisted mainly in keeping patient-specific records of healthcare service delivery, maintaining e-case histories, booking doctor’s appointments online and gradually putting electronic document control systems in place. There has been no clear legal framework for exchanging telemedical data.
In 2016, a relevant bill (1) (the Bill) was put
forward for public debate. Authored by the
Healthcare Ministry, the Bill offers much broader
opportunities for both doctors and patients. It
has been approved by the Russian Economic
Development Ministry and is backed by the
Russian Government’s Expert Council, so it is
expected to be presented to the State Duma
soon. The Bill is specifically proposed to cover:
● arranging distant visits to a healthcare practitioner followed by issue of patient assessment reports and treatment advice;
● holding distant case conferences;
● issuing e-prescriptions;
● using telemetric data (remote exchange of health-related information between patients and doctors, including in real time);
● maintaining electronic patient histories and exchanging information between companies and government agencies involved in healthcare.
If the Bill is passed as it is, without the scope of eligible telemedical activities being narrowed considerably, the appetite of telecommunications and pharmaceuticals players for this niche can be expected to grow rapidly, especially if government subsidies are available for distant healthcare and monitoring systems in the public sector.
On the other hand, private clinics are more likely to be the first to offer their patients telemedicine benefits. Many of them have already passed a number milestones of digital technology (common electronic medical record and e-booking systems, remote consultations and document exchange between doctors), while these are only just beginning to make their way into public healthcare. Insurance companies can help roll out the service: if telemedicine packages are covered by private health insurance policies, this might speed up their implementation in healthcare facilities and help patients adapt quickly to the new services. A prime example is offered by the U.S., where major insurers are increasingly listing telemedical services in their policies(2).
Barriers to Telehealth
Despite the many potential benefits offered for patients in the very near future by the advance of telemedicine, such technologies might come up against both practical (clinics and patients lacking the necessary equipment) and legal complications.
For instance, data privacy and protection issues have been climbing higher and higher on the agenda in recent years. Russian legislation treats any information about patients’ health as “special” personal data(3), which may be processed only in extremely limited circumstances (including with the patient’s consent).
Given the particular importance of healthrelated information, telehealth operators and all parties involved in data exchange must maintain a high level of security, using cryptographic information protection tools and facilities, which might be subject to licensing(4).
In its current version, the Bill requires any parties involved in data exchange within telemedicine IT systems to use qualified digital signatures(5). These are the most secure type of e-signature, verified by e-certificates issued by accredited centers. This tool authenticates electronic medical records, yet it adds to the cost and complexity of creating and integrating them owing to cryptographic protection and the need to engage a specialized firm to verify digital signature certificates.
In addition, it is equally important to protect patients against unqualified distant medicare: as they advance, digital technologies have always been haunted by new types of fraud and telemedicine might also encounter unscrupulous individuals who generate unlicensed (non-compliant) “virtual doctor’s offices” seeking to access patients’ personal data and money by deception. Since regulation of medical services is the responsibility of the Healthcare Ministry, whereas personal data protection and telecom networks regulation are up to the Communications and Media Ministry (Minkomsvyaz) and the Federal Supervisory Service for Communications, Information Technology and the Media (Roskomnadzor), it is also vital for the role of watchdog over telehealth service terms and conditions to be distributed clearly and in detail when the Bill and its by-laws are further developed.
Control of telemedicine quality might also be promoted by market players setting up a selfregulating organization to assist businesses and the government elaborate a common system for assessing the quality of services and telemedicine service requirements (like MAST(6) (Model for Assessment of Telemedicine) in Europe).
As time goes by, all these complications will no doubt be left behind but, once these services are ready for release onto the mass market, not only must their key features be secured in legal documents but also their user friendliness be guaranteed and patient awareness and safety procured.
(1) “On Amending Certain Legislative Acts of the Russian Federation Concerning Application of Information and Telecommunications Technologies and Introduction of Electronic Documents in Healthcare,” http://regulation.gov.ru/projects#npa=46654
(3) article 10, Federal Law No. 152-FZ dated 27 July 2006 “On Personal Data.”
(4) Article 12, Federal Law No. 99-FZ dated 4 May 2011 “On Licensing Certain Activities”
(5) Article 5, Federal Law No. 63-FZ dated 06 April 2011 “On Electronic Signatures”
* Goltsblat BLP is the Russian practice of Berwin Leighton Paisner (BLP), an award-winning international law firm headquartered in London and with offices operating in major commercial and financial centres
throughout the world — Moscow, Abu Dhabi, Beijing, Berlin, Brussels, Dubai, Frankfurt, Hong Kong, Paris and Singapore, Tel Aviv and Yangon.
The firm has a team of 100 Russian, English and US law qualified lawyers based in Moscow and over 800 lawyers in the other international offices.
Goltsblat BLP currently has over 1300 clients among the major international investors operating in Russia, including 37 Fortune 500 companies.
Tel:+7 (495) 287 44 44