Health informatics governance Flashcards
What is required to ensure confidentiality and data protection?
Adequate training in data protection
Compliance with data protection act 1998
Organisational policies and procedures
Audit process and evidence of compliance
What are the requirements of the data protection act 1998?
Data should be: Fairly and lawfully processed Processed for limited purposes Sufficient and relevant Accurate Not stored for longer than necessary Processed in line with data subject's rights Secure Transferred only to countries with adequate security
What are the caldicott principles related to?
Use and transfer of patient identifiable data other than for direct care, medical research, or statutory requirement
What are the duties of a Caldicott Guardian?
Strategy and governance
Confidentiality and data protection expertise
Internal information processing
Information sharing
What are required for information security assurance?
Adequate skills Established business processes Choice of IT systems supports security requirements Business continuity plans Identifiable information assets Network access security
What are required for clinical information assurance?
Adequate skills and knowledge
Correct use of NHS number
Procedures for accuracy of clinical information
What are required for secondary uses assurance?
National data definition standards
Maintain external data quality standards
Audit clinical coding accuracy
Validation processes for clinically coded data
Who is the competent authority in the UK to implement the MDD
MHRA
Who are the notified body?
Company accredited to assess device against CE mark
What are the practical considerations for software with a CE mark?
Development must follow a recognised software lifecycle
Risk analysis
Scrutiny of process as well as product
Why is it important that systems are managed appropriately?
Could affect diagnosis or treatment
Patient pathway can involve several medical devices
System admin and interoperability may affect outcomes
Should be managed as part of a process
