A Bill to amend and supplement the Health Act (“the Bill”) has been introduced in Parliament. The purpose of the Bill is to regulate the provision of treatment, rehabilitation and preventive services at a distance – so-called “telemedicine”. Here are the main proposals:
Persons who will be able to provide telemedical services
The services can be carried out by Bulgarian citizens or foreign citizens of an EU Member State, other countries of the European Economic Area and Switzerland. Some of the conditions they must meet to qualify are:
- For the professional field “Medicine” and “Dentistry”, they must have obtained a Master’s degree or equivalent (the education may also have been obtained abroad) and should be entered in the register of the respective professional organization;
- For the professions “Nurse” and “Obstetrician”, candidates must have obtained a bachelor’s degree and be entered in the register of the relevant professional organization;
- For rehabilitation therapists and paramedics – they must have obtained a bachelor’s degree or have a certificate of professional qualification, as well as be entered in the register of the relevant professional organization.
Along with this, there are standard requirements such as no former convictions, proof of the above requirements, proof of technical proficiency on the platform that will be used to provide the telemedical services, etc.
Registration
The activity is to be subject to registration and the registration is to be carried out by the Executive Director of the Executive Agency for Medical Supervision (“EAMS” or “the Executive Agency”). The application for registration itself will be submitted to the competent unit of the Regional Health Inspectorate.
If all the requirements are met, the Executive Director of EAMS will issue a certificate of registration within one month of receipt of the application. A public register of all registered natural and legal persons providing telemedical services will be kept at the EAMS.
Providing telemedical services
On a case-by-case basis, a decision will be made as to whether telemedicine is an appropriate approach, with the deciding specialist being responsible for this. Factors such as clinical appropriateness, quality, and safety will be considered for this purpose.
The use of telemedicine as an approach will also require explicit informed written consent from the patient, or their parent or legal guardian.
Control
The Bill proposes the control of this new type of activity to be carried out by the EAMS. Reports will be submitted by the patient, respectively their parent, legal guardian, or by a person authorized for this purpose. The control itself will be carried out by means of inspections, which the EAMS is obliged to carry out within 7 days from the receipt of a report. The short timeframe for carrying out these inspections does raise some concerns, and the Executive Agency itself draws attention to this, as set out below.
Criticisms of the Bill
In the course of the legislative process, opinions on the proposed Bill were requested and received. Noteworthy are the EAMS’ comments, which is in charge of exercising control over the provision of telemedical services. The opinion of the Executive Agency is highly critical, drawing attention primarily to the following shortcomings of the Bill:
- As the natural and legal persons registered under the Bill will not have the status of a “medical institution”, a number of strict regulatory requirements applicable to medical institutions will be circumvented;
- It is not specified what number and type of specialists each applicant should have for this new type of activity;
- There is no regulation regarding the financial security of the applicants, which is a guarantee for the right of patients to receive timely and accessible medical care;
- There is a lack of clarity concerning the documentation required when working with each patient, which itself will be the basis for the control exercised by the EAMS;
- Excessively short deadlines for inspections.
Critical opinions have so far also been received from the Association for the Development of Bulgarian Healthcare, the National Association of General Practitioners in Bulgaria, the Bulgarian Dental Union, the Bulgarian Association of Dental Technicians. All this suggests with a high degree of certainty that the Bill will undergo significant amendments before it is voted on.
