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AAMI TIR57:2016/(R)2019 - Principles for medical devices security-Risk management, 2016
- AAMI TIR57:2016, Principles for medical device security—Risk management
- Title page
- AAMI Technical Information Report
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Foreword
- Introduction [Go to Page]
- Figure 1 - Schematic representation of the risk management process (ANSI/AAMI/ISO 14971:2007)
- Figure 2 – A Venn diagram showing the relationship between security and safety risks
- 1 Scope
- 2 Terms and definitions
- 3 General guidance for performing security risk management [Go to Page]
- 3.1 Security risk management process [Go to Page]
- Figure 3 - Schematic representation of the security risk management process
- 3.1.1 Relationship between security and safety risk management [Go to Page]
- Figure 4 – Relationships between the security risk and safety risk management processes
- 3.2 Management responsibilities
- 3.3 Qualification of personnel
- 3.4 Security risk management plan
- 3.5 Security risk management file
- 4 Security risk analysis [Go to Page]
- 4.1 Security risk analysis process
- 4.2 Intended use and identification of characteristics related to the security of the medical device
- 4.3 Identification of threats, vulnerabilities, assets, and adverse impacts [Go to Page]
- 4.3.1 Identification of threats
- 4.3.2 Identification of vulnerabilities
- 4.3.3 Identification of assets
- 4.3.4 Identification of adverse impacts
- 4.4 Estimation of the risk(s) for each applicable threat and vulnerability combination
- 5 Security risk evaluation
- 6 Risk control [Go to Page]
- 6.1 Security risk reduction
- 6.2 Security risk control option analysis
- 6.3 Implementation of risk control measure(s)
- 6.4 Residual risk evaluation
- 6.5 Risk/benefit analysis
- 6.6 Risks arising from risk control measures
- 6.7 Completeness of risk control
- 7 Evaluation of overall residual security risk acceptability
- 8 Security risk management report
- 9 Production and post-production information
- Annex A, Security engineering principles and nomenclature [Go to Page]
- A.1 Overview
- A.2 Uniqueness of embedded medical systems
- A.3 Stakeholders
- A.3.1 Patients, family, friends, and caregivers
- A.3.2 Regulators
- A.3.3 Health Delivery Organizations (HDOs)
- A.3.4 Manufacturers
- A.3.5 Academics
- A.3.6 Cyber Liability Insurers
- A.4 Security objectives and goals
- A.5 Considerations for emergency access
- A.6 Medical device security architecture considerations
- Annex B, Security risk assessment [Go to Page]
- B.1 Risk assessment process [Go to Page]
- Figure B.1 - A basic high-level risk assessment process
- B.1.1 Prepare for assessment
- B.1.2 Conduct assessment
- B.1.3 Communicate results
- B.1.4 Maintain assessment
- B.1.5 Other security risk assessment processes [Go to Page]
- B.1.5.1 Common vulnerability scoring system (CVSS)
- B.1.5.2 Open web application security project (OWASP)
- B.1.5.3 Attack trees
- B.2 Risk model [Go to Page]
- B.2.1 Threat assessment [Go to Page]
- B.2.1.1 Characteristics of adversarial threats
- B.2.1.2 Threat events
- B.2.1.3 Example threats
- B.2.2 Vulnerability assessment [Go to Page]
- B.2.2.1 Example vulnerability classes
- B.2.3 Impact assessment [Go to Page]
- B.2.3.1 Asset inventory
- B.2.3.2 Asset identification
- B.3 Assessment approaches
- B.4 Security analysis approaches
- B.5 Assessing security risk
- Annex C, Generating cybersecurity requirements
- Annex D, Questions that can be used to identify medical device security characteristics [Go to Page]
- D.1 Essential performance
- D.2 Data storage [Go to Page]
- D.2.1 PII/Private data assets
- D.2.2 Non-PII data assets
- D.3 Data transfer
- D.4 Authentication & authorization
- D.5 Auditing
- D.6 Physical security
- D.7 Device/system updates
- D.8 Hardening
- D.9 Emergency access
- D.10 Malware/virus protection
- D.11 Backup/disaster recovery
- D.12 Labeling
- Annex E, Security risk examples applied to a medical device [Go to Page]
- E.1 The Kidneato System [Go to Page]
- Figure E.1- Block diagram of the Kidneato system, managed environment
- Figure E.2 – Block diagram of the Kidneato system, patient environment
- E.2 Kidneato programmer
- E.3 In-home monitor (IHM)
- E.4 Web services
- E.5 Web services - Direct access
- E.6 Web services - Instrument access
- E.7 Example implementations [Go to Page]
- E.7.1 Example #1 Basic Cyber Hygiene [Go to Page]
- E.7.1.1 Security analysis
- E.7.1.2 Security risk evaluation [Go to Page]
- Table E.1 - Security risk evaluation table
- E.7.2 Example #2 Implant Communications [Go to Page]
- E.7.2.1 Security analysis
- E.7.2.2 Security risk
- E.7.2.3 Likelihood
- E.7.2.4 Impact
- E.7.2.5 Risk estimation [Go to Page]
- Table E.2 - Risk estimation analysis example
- E.7.2.6 Implemented control
- E.7.2.7 Residual risk estimation [Go to Page]
- Table E.3 - Residual risk estimation analysis example
- E.7.2.8 New risk identification
- E.7.3 Example #3 WCA Firmware Update [Go to Page]
- E.7.3.1 Initial Design
- E.7.3.2 Attack of the Design
- E.7.3.3 Results from the Attack
- E.7.3.4 Analysis
- E.7.3.5 Security Risk Controls
- Annex F, A comparison of terminology between key referenced standards [Go to Page]
- Table F.1 - Related terms in security standards/technical reports
- Bibliography [Go to Page]