Laws and regulations

Laws related to the domain
LOPD  Organic Law on the Protection of Data (LO 15/1999); and implementing regulations (RD 994/1999 on security and last amended in 2007, el RD-1720/2007).
LAPOrganic Law of Autonomy of the patient (LO 41/2002).
LIBBiomedical Research Act (LO 14/2007).
Computer Systems Validation in Clinical Research. A practical Guide. ACDM/PSI
Good Practices for Computarizad Systems in regulated "GXP" Environments. PIC/S.
Guidance for Industry and FDA Staff. Guidance for the Content of Premarket Submissions for Software Container in Medical Devices. U.S. Department of Health and Human Services.
CoBIT. Control Objectives for Information and related Technology. ISACA (Information Systems Audit and Control Association), ITGI (IT Governance Institute).
CMMI. Capability Maturity Model Integration
ISO/IEC 20000
ISO 27001
ITIL. Information Technology Infrastructure Library


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