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Sjukhusövergripande datalager för vitalparametrar: Sammanställning av regelverk och riktlinjer
KTH, School of Technology and Health (STH).
KTH, School of Technology and Health (STH).
2015 (Swedish)Independent thesis Basic level (degree of Bachelor), 10 credits / 15 HE creditsStudent thesisAlternative title
Hospital Shared Data Warehouse for Vital Signs : Compilation of legal frameworks and guidelines (English)
Abstract [sv]

I samband med uppbyggnaden av Nya Karolinska Solna designas ett nytt sjukhusövergripande datalager för vitalparametrar, med arbetsnamnet T5, där insamlad data ska följa patienten genom hela sjukhusvistelsen.

Inför upphandlingen av systemet behövs en genomgång av vilka standarder, regelverk samt riktlinjer som gäller vid framställning och drift av T5. Genom djupgående litteraturstudier och intervjuer med personer insatta i områden som anses relevanta för projektet, levereras som slutprodukt en rekommendation om hur regelverken och standarderna kan tänkas appliceras på systemet.

Projektets resultat visar att om det data som hanteras i T5 är tänkt att användas i medicinskt syfte enligt Lagen om medicintekniska produkter, så är systemet en medicinteknisk produkt. Vidare bör systemet klassificeras som riskklass I, förutsatt att informationen i T5 inte ska användas för patientövervakning i realtid.

Abstract [en]

As the opening of emergency hospital Nya Karolinska Solna approaches, a data warehouse for vital signs is being designed. The system is referred to as T5 and the intention is to allow collected medical data to follow the patient throughout the entire hospital stay.

Before the procurement of the system there is a need for a review of legal frameworks, standards and guidelines applicable to T5. The project was carried out through research of documents and interviews with professionals involved with subjects relevant to the project. As a final product, a recommendation on how the standards and legal frameworks could be applied to the system was compiled.

Project results show that if data managed in T5 is aimed to be used in a medical purpose, the system qualifies as a medical device. Furthermore, the system should be classified according to hazard class I, assuming that the information in T5 will not be used for real time monitoring of patient conditions.

Place, publisher, year, edition, pages
2015. , 20 p.
Series
TRITA-STH, 2015:42
Keyword [sv]
medicinsk teknik, medicinsk mjukvara, informationshantering, datalager, medicinska regelverk, CE-märkning
National Category
Medical Engineering
Identifiers
URN: urn:nbn:se:kth:diva-169702OAI: oai:DiVA.org:kth-169702DiVA: diva2:824883
External cooperation
Karolinska Universitetssjukhuset, Solna
Subject / course
Medical Engineering
Educational program
Master of Science in Engineering - Medical Engineering
Supervisors
Examiners
Available from: 2015-06-24 Created: 2015-06-22 Last updated: 2015-06-24Bibliographically approved

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CiteExportLink to record
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Citation style
  • apa
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Output format
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