Today, there is practically no doubt that the private sector of the medical business will rapidly develop in Ukraine in the near future. Therefore, many professionals working in this field are aware of the need to open a private medical practice.
If you are one of them, you just need to know about the basic legal aspects of organizing and running a medical business, potential problems and how to solve them.
Elena Radzievskaya – lawyer, partner of the Interregional Bar Association – in an interview for estet-portal.com, she spoke about the specifics of working in the field of medical services.
Elena Radzievskaya – lawyer, partner of the Interregional Bar Association
What are the main problems an entrepreneur faces when opening a private medical practice
The main problem, which is fundamental to a number of other problems, is outdated legislation regulating the activities of medical institutions. Often when working, you have to use regulations that were adopted at a time when private medical practice was supplanted by a huge network of public health facilities. The system of sanitary norms and rules, which was formed back in Soviet times, also does not meet either the requirements of modernity or international practices.
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Today, the state also does not provide equal opportunities for the functioning of medical institutions of all forms of ownership (as provided for in Article 49 of the Constitution of Ukraine). Currently, state institutions have many advantages over non-state ones (permitting system, taxation, advantages in licensing, accreditation of medical staff, use of drugs, sick leave, etc.).
In the situation of the virtual absence of state regulation of the development of the private healthcare sector and an appropriate legal framework, there is also no coordinating body or professional association of private practitioners that would ensure the real development of the private medical sector by lobbying its interests at the legislative level, by solving legal questions, helping beginners, providing opportunities for advanced training, etc.
The more competently and professionally the preparatory activities will be carried out – the easier and faster will be overcome the difficulties of the beginning of activity, as well as the problems that lie in wait for the doctor in his daily work.
Besides, the medical system is now going through one of the most painful stages of reform. As a result of the ongoing reform, for example, the Sanitary and Epidemiological Service of Ukraine was liquidated, the functions of which are currently distributed between the Ministry of Agrarian Policy and Food of Ukraine and the Ministry of Health of Ukraine. The controlling function of the former SES was transferred to the State Service of Ukraine for Food Safety and Consumer Protection. As a result of the ongoing reform, it is planned to create a Public Health Center, the functions of which will largely coincide with the tasks that the SES has been performing for many decades.
In the current situation of regular redistribution of powers between state bodies, in practice, one may encounter a banal problem of determining the authorized body for attesting the premises and obtaining conclusions regarding its compliance with the requirements of sanitary legislation.
Again, finding suitable premises can be a problem for an entrepreneur at the stage of opening a private medical practice, since the market for such real estate is limited, and the presence of premises that have been approved for compliance with sanitary and fire safety standards is a necessary condition for obtaining a license from the Ministry healthcare of Ukraine.
There is also the issue of regular certification of medical personnel of private medical institutions, solutions to which should be found immediately when organizing and opening a private practice.
That is, there are problems, but they are surmountable. This is evidenced by the experience of private medical institutions, which have already proven their viability in various areas of medical care. As with opening a private practice in any other area, the more competently and professionally the preparatory activities will be carried out – the easier and faster will be overcome the difficulties of the beginning of activity, as well as the problems that lie in wait for the doctor in his daily work.
What, from a legal point of view, is the specifics of working in the field of medical services
Our experience is that, regardless of the industry in which our clients operate, the issues and problems they face are somewhat of the same type. At the same time, each field of activity imposes its own specifics, and, of course, to a large extent this applies to medical practice.
For example, as of today, the issue of protecting the rights of a doctor (as well as the rights of a patient) remains open at all. According to the Criminal Code of Ukraine, there are more than 15 articles under which a medical worker can be held criminally liable. At the same time, there are practically no normatively approved standards in Ukraine that would regulate the actions of a doctor in applying topical preventive, diagnostic and therapeutic measures, based on the available evidence of their effectiveness and security; in the same way, there is no sufficient amount of clinical research materials; but there is a "lag effect". Accordingly, at the time
There is also no well-formed judicial practice regarding disputes that arise in the provision of medical services, which is explained by the difficulty of collecting evidence and, accordingly, the difficulty of defending a legal position in court.The issue of formalizing relations with a patient is of great specificity. First of all, this is due to the fact that in order to provide a quality medical service, the doctor must receive and record information about the patient's health status, date of birth, place of residence, contact numbers, etc. Such a set of data about an individual who is identified or can be specifically identified is defined by law as a database of personal data, for the storage and processing of which special requirements and responsibilities are established by law.
The issue of formalizing the relationship with the patient is of great specificity.Today, medical records have become electronic medical records. Data in the medical records of patients is accumulated, systematized and, accordingly, attract intruders. According to some reports, on the black market, the cost of medical information about a person can be 10 times higher than the price of financial information about him (account numbers, credit cards, transactions, and so on). And the higher the level of the clinic, the more attractive the data about its clients. Nevertheless, even a small medical institution falls under very strict legal requirements regarding the safety of patients' personal data, their integrity and the appropriate access to them.
Another difficult problem for medical institutions – ensuring the legality of the processing of personal data of patients. In the Law of Ukraine "On the protection of personal data" a separate article is provided, which defines one of the cases when it is possible to work with personal data without the consent of the client – when such processing is necessary for the purposes of protecting health, establishing a medical diagnosis, providing treatment or providing medical services. At the same time, a very inconvenient restriction is spelled out there: everyone who works with a special category of personal data must be professional doctors or persons who are subject to the legislation on medical secrecy, otherwise it is necessary to obtain written consent or look for another basis for processing.
Thus, another issue that has its own specifics in the medical field is the issue of formalizing relationships with the staff of a medical institution, whose labor function may include both the processing and storage of personal data of patients.
Advertising of medical services also has its own specifics. As you know, the best advertisement for a doctor – These are the recommendations of his patients. Nevertheless, in the conditions of developing competition in the medical services market, the issue of advertising becomes relevant, and high-quality marketing of medical services is already an indispensable attribute of a successful medical business. It should be borne in mind that the legislator has established a large list of requirements and restrictions that relate to the advertising of medicines, medical equipment, methods of prevention, diagnosis, treatment and rehabilitation. Medical marketing is characterized by a very high threshold for error sensitivity. Sometimes only a specialist (lawyer, linguist, etc.) can determine the fine line between what is permitted and what is not permitted in such advertising. At the same time, the persons
In the conditions of developing competition in the medical services market, the issue of advertising becomes relevant, and high-quality marketing of medical services is already an indispensable attribute of a successful medical business.
In all of the above, I have tried to highlight only some of the specific legal issues in the field of medical services that will lie in wait for private practitioners in their activities, but there are many other small issues that arise every day and require the right decisions in accordance with with current legislation.
Is it possible to build a business in the medical field, which is called "according to the rules"
Not only possible, but necessary. The strategy for developing a successful medical business is quite simple: the business must be long-term in order to be profitable.
In order to ensure the longevity of such a business, a healthy and strong foundation must be laid for it from the outset. Issues of choosing an organizational and legal form, registration of relations between founders, control mechanisms, issues of choosing a taxation scheme, issues related to registration of rights to real estate, registration of relations with suppliers and partners, issues of developing a standard contractual framework for registration of relations with patients and employees, regulation of the formation procedure and functioning of personal databases of both patients and employees, etc. must be thought out with the prospect that the business will grow and develop with the possible attraction of new investors.
Only if these issues are initially resolved in accordance with applicable law, in the long term, in the process of business development, there will be no issues related to the need to act not "by the rules".
The strategy for developing a successful medical business is quite simple: the business must be long-term to be profitable.
Obviously, for such work it is advisable to involve people with special knowledge and experience, as well as a vision of what issues may arise in the future and what problems should be prevented at the initial stage.
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