Medical software apps (Health Apps) – characteristics, examples, legal perspective
Publication date: April 04, 2025
Introduction
Adherence Day has been established by the International Society of Hypertension. “Adherence” is an English-language term used in medicine and refers to the extent to which a patient’s behavior (in terms of taking medications, following a diet, and making lifestyle changes) is consistent with medical recommendations (sensu largo), as well as to the appropriate dose and time of taking medications (sensu stricto). The opposite of adherence to therapeutic recommendations is referred to as “non- adherence” or “non- compliance”. The latter is a very negative and undesirable phenomenon in society, not only because of its health effects, but also because it generates huge costs for healthcare systems around the world. Scientific studies show that in the case of chronic diseases, many patients stop taking their medications on their own after 6-12 months or take them unsystematically, which negatively affects the entire treatment process (in the case of people with hypertension, about 58% stop following the doctor’s recommendations after a year, which leads to a deterioration in the quality and shortening of life, and the risk of death due to cardiovascular diseases increases by 30%). Moreover, it is estimated that each year in Europe, improper use of medications costs about 125 billion euros, and in Poland six billion zlotys. These amounts include, among others, hospitalizations that could have been avoided and repeated sick leave. Against this background, concepts of creating software and applications for mobile devices that would improve patients’ systematic compliance with medical recommendations and make it easier for doctors to monitor patients’ progress in the implemented therapy are increasingly appearing in the scientific and technological discourse.
KIELTYKA GLADKOWSKI KG LEGAL TOOK PART IN LIFE SCIENCE CLUSTER WEBINAR ON CERTIFICATION OF MEDICAL DEVICES
Publication date: March 31, 2025
The meeting was devoted to the classification of medical devices. The main topic was the technical and legal classification and certification of medical products and diagnostic devices before they are introduced to the market. This process is very time-consuming and even very expensive.
It is worth using the help of a company that provides assistance in this procedure during this process. It is important that this company is a notified body, a conformity assessment body designated in accordance with Regulation 2017/745. Then you can be sure that a given product intended to take care of human health will be properly put into clinical trials and will be safe for people.
Connected Health Ecosystems via Open Innovation (COHES.io) – A New Era of Health Innovation digital
Publication date: March 31, 2025
The healthcare sector is one of the most challenging areas of innovation, characterized by high complexity, strict regulations, high development costs and cultural diversity in different countries. Despite technological progress, fragmentation of innovation ecosystems in digital health is a significant barrier to effective cooperation and implementation of new solutions. The COHES.io project (Connected Health Ecosystems via Open Innovation), which aims to create an interregional space for open innovation in digital health, is the response to these challenges.
Permission to manufacture or import a medicinal product – administrative procedure and detailed requirements for factories
Publication date: March 31, 2025
In recent years, there has probably been no more dynamically developing market sector than that closely related to the production of drugs, their testing and introduction to consumer circulation. Especially during the COVID-19 pandemic caused by the SARS-CoV-2 coronavirus, all the efforts of pharmacists around the world have been focused on developing an effective formula for a vaccine protecting against infection with this disease, producing it, testing it and making it available to people, and in the longer term on developing a formula for a drug that could be widely used, e.g. in hospitals. No less important at that time were the problems and legal issues related to obtaining permission to produce drugs. In this article, there will be discussed detailed regulations related to the procedure for obtaining consent to manufacture drugs, which is regulated in the Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2024, item 686; amended: Journal of Laws of 2025, item 129), as well as to present the requirements imposed on drug factories in terms of building equipment and production principles, which are regulated in other sub-statutory legal acts.
