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). |
| LAP | Organic Law of Autonomy of the patient (LO 41/2002). |
| LIB | Biomedical 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. |
Regulations
| 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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