Aspekty prawne REJESTRÓW MEDYCZNYCH


Jak zrozumieć czym są rejestry medyczne? Ich definicji istnieje co najmniej kilka. Zazwyczaj mówi się o bazach danych przechowujących informacje dotyczące opieki nad pacjentem. Można je też ujmować jako wiedzę zgromadzoną dla celów publicznych. Wiedzę zarówno o zdrowiu, jak i demografii. Wydaje się jednak, iż prym obecnie wiodą – pod względem zainteresowania nimi – rejestry medyczne obejmujące określoną jednostkę chorobową czy terapię, kurację lub lek wraz z rozległymi danymi o ich wpływie na pacjenta.

 

Bez względu jednak na rodzaj definicji czy precyzję, z jaką definiujemy rejestry medyczne, niezmiennie ważnym pozostaje aspekt ich prawnego usankcjonowania. Zgromadzone informacje powinny być bowiem skutecznie zabezpieczone przed czynnikami zagrażającymi i złymi intencjami osób postronnych. Zerknijmy na normy prawne, które tę kwestię regulują.

 

Rejestry medyczne a ochrona danych osobowych

 

Punktem odniesienia dla rozporządzeń krajowych przestrzeganych w państwach członkowskich Unii Europejskiej jest Dyrektywa 95/46/We Parlamentu Europejskiego i Rady Europy z 24 października 1995 roku w sprawie osób fizycznych w zakresie przetwarzania danych osobowych i ich swobodnego przepływu. W Polsce podobną ustawę – Ustawę o ochronie danych osobowych – zatwierdzono 29 sierpnia roku 1997. Oba zapisy zgodę na przetwarzanie osobowych danych medycznych traktują na zasadach wyjątku od zakazu przetwarzania danych wrażliwych, takich jak: pochodzenie rasowe lub etniczne, opinie polityczne, przynależność religijna czy związkowa, a także zdrowie i życie seksualne. Wyjątek stanowi pisemna zgoda osoby, której te dane dotyczą, cel związany z ochroną zdrowia (ochrona stanu zdrowia, świadczenie usług medycznych bądź leczenie pacjentów), a także cel naukowy. Jednak z zastrzeżeniem, że w wymienionych warunkach należy zagwarantować danym osobowym pełną ochronę.

 

Przy uwzględnieniu wyłącznie takich zapisów i ustaw byłoby niezwykle trudno tworzyć rejestry medyczne i korzystać z nich – czy to do celów administracyjnych, czy też naukowych. Ograniczają one również funkcje informacyjne i statystyczne. Zgoda powinna być co prawda dobrowolna i świadoma, jednak osoba jej udzielająca nie musi mieć poczucia zależności pomiędzy jej udzieleniem a zrealizowaniem przez podmiot leczniczy świadczenia zdrowotnego. Niemożliwym byłoby również ustanowienie naczelnej bazy danych – większego rejestru medycznego, który zbierałby informacje z wielu placówek.

 

Gromadzenie danych w rejestrach medycznych bez zgody osoby, której te dane dotyczą

 

Po wejściu w życie Ustawy z 28 kwietnia 2011 roku o systemie informacji w ochronie zdrowia, tworzenie rejestrów medycznych zostało znacząco ułatwione. Teraz to nie osoba badana decyduje o udostępnianiu danych osobowych, lecz Minister Zdrowia na mocy konkretnych rozporządzeń – to on może tworzyć, prowadzić lub zlecać prowadzenie rejestrów medycznych, czyli uporządkowanego zbioru danych o zachorowaniach, stanie zdrowia, metodach leczenia i stawianych diagnozach, monitorowaniu postępów i  wykrywanych zagrożeniach chorobotwórczych.

 


16 215 odpowiedzi na “Aspekty prawne REJESTRÓW MEDYCZNYCH”

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