Medical Registers

Evaluating the Quality of Medical Treatment

The legal functioning of medical registers in Poland
is regulated by the Act of 28 April 2011 on the health care information system.
In accordance with applicable regulations,
medical registers:
  • develop and managed (or develop and commissioned to conduct by entities performing medical activities) the Minister of Health;
  • is developed in a specific typologies of diseases, ranges (diseases: blood and blood-forming organs, cancer, cardiovascular / genitourinary, nervous / respiratory / digestive, rare diseases);
  • are implemented based on an analysis of the needs for their creation;
  • are created and closed by way of an Ordinance of the Minister of Health;
  • include data provided by entities maintaining public and medical registers as well as by service providers - the administrator of data is the Minister of Health.
New quality of medical records.

Due the constantly growing importance of improving quality in healthcare, it is assumed to develop appropriate regulations that will allow monitoring and increasing its quality - the set of regulations is to be made by the Act on quality in the protection of patient's health and safety. The process of legislative work on a new legal act was based on the draft statutory assumptions of January 20 this year - its goal is to develop and implement legal and organizational solutions that allow to coordinate and comprehensively implement key aspects of health policy in the area of ​​quality.

The aforementioned project assumes, among others implemmentation of new solutions in the field of functioning of medical registers. The registers are to allow the determination of clinical quality indicators for healthcare providers, which is to be the basis for a new system of monitoring the effectiveness and safety of therapeutic activities. It is expected that development of indicators of this type will allow:

  • assess the quality of health services provided by individual entities or assess applicable procedures, medical technologies as well as medicinal products and medical devices in real conditions;
  • constantly improve clinical practice, including - improve the safety and effectiveness of patient care.

In connection with the purposes of keeping medical records defined in this way, it is recommended to develop them in a way that allows them to acquire knowledge in the field of the legitimacy of the used treatment method, efficacy relevant to the patient, his safety (complications, adverse events) and technologies tested as part of the registers.

In addition, it is assumed that new medical registers will be created according to the so-called principles of good practice and financed or co-financed by the Minister of Health from public funds and they will be avaiable for all patients meeting the criteria for inclusion, i.e. patients:

  • with a specific diagnosis, medical condition;
  • undergoing specific therapy, specific treatment - e.g. a register of procedures or operations;
  • who used a specific medicinal product (phase IV clinical trial);
  • who have used a specific medical device - e.g. a register of implanted hip replacements.
It is expected that the legal act of quality in health care and patient safety will be implement at the beginning of 2018, supplementing the regulations included in the Act of 28 April 2011 on the information system in healthcare. The obligation to adapt the currently operating medical registers to the new requirements set out in regulations by the end of 2021 - until then the currently operating medical registers, defined by way of ordinances, will operate on the current principles.
BioStat Medical Registers.

Aware that the medical environment requires a thorough analysis of the results of treatment in order to improve the effectiveness and safety of the provided care, we offer an IT service of developing advanced medical records, gathering data of individual patients in accordance with applicable rules and standards.

Our solutions are based on the integrated research platform eCRF.bizTM, which enables the collection, processing and analysis of valuable epidemiological data - programming solutions developed over the years ensure that our clients' data are properly secured, and the registers themselves allow for effective statistical and observational research, epidemiological and clinical for stages I-IV. All types of research can be conducted in a convenient electronic form, using user-friendly online surveys.

Rejestry medyczne
Transparency - the registers are equipped with a statistical module that presents research results in an accessible way, as well as they cooperate with an intuitive web application;
Rejestry medyczne
Functionality - the registers are equipped with mechanisms for querying entries, checking the correctness and completeness of entries (at the data entry stage) and tracking changes in the value of entries (audit trial), as well as the possibility of introducing changes during the examination and printing of completed CRF forms;
Rejestry medyczne
Ease of use - the registers operate on the basis of multiple access, they are characterized by the ease of creating and testing forms, and in case of difficulties we provide support of a team of experienced IT specialists and statisticians;
Rejestry medyczne
Security - the registry system complies with Title 21 CFR Part 11 FDA guidelines and is equipped with an automatic backup module.

Frequently asked questions.

What types of medical registers can we distinguish?
  • Pharmacy register,
  • Medicinal products register,
  • Entity register,
  • Center register,
  • Coding systems register.
Does Biostat's offer include contracting centers?
Absolutely. Biostat provides services for contracting centers and researchers in clinical and observational studies.
Our specialists negotiate bilateral, trilateral, and quadrilateral agreements. With the principle that trilateral and quadrilateral agreements are always concluded in traditional paper form. For bilateral agreements, we use the™ system's feature for online contracting. With this solution, there's no need to print, scan, and send documents by courier.
Are there any particular therapeutic areas in which Biostat employees have experience?
In reality, our experts have the resources and knowledge to conduct a study in any field. However, we have the most medical experience in therapeutic areas such as oncology, gastroenterology, transplantology, cardiology, neurology, allergy, psychiatry, neonatology, diabetology, pulmonology, immunology, andrology, proctology, dermatology, ophthalmology, rheumatology, virology, and hematology.
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