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AAMI TIR5 2016 R2023

AAMI TIR5 2016 R2023

$172.67

AAMI TIR57:2016 (R2023) Principles For Medical Device Security – Risk Management

Published By Publication Date Number of Pages
AAMI 2016 84
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This technical Information Report (TIR) provides guidance on methods to perform information security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971. The TIR incorporates the expanded view of risk management from IEC 80001-1 by incorporating the same key properties of Safety, Effectiveness and Data & Systems Security with Annexes that provide process details and illustrative examples.

PDF Catalog

PDF Pages PDF Title
1 AAMI TIR57:2016/(R)2023; Principles for medical device security—Risk management
3 Title page
4 AAMI Technical Information Report
Copyright information
5 Contents
6 Glossary of equivalent standards
7 Committee representation
9 Foreword
10 Introduction
11 Figure 1 – Schematic representation of the risk management process (ANSI/AAMI/ISO 14971:2007)
12 Figure 2 – A Venn diagram showing the relationship between security and safety risks
15 1 Scope
2 Terms and definitions
19 3 General guidance for performing security risk management
3.1 Security risk management process
20 Figure 3 – Schematic representation of the security risk management process
3.1.1 Relationship between security and safety risk management
21 Figure 4 – Relationships between the security risk and safety risk management processes
3.2 Management responsibilities
22 3.3 Qualification of personnel
3.4 Security risk management plan
23 3.5 Security risk management file
4 Security risk analysis
4.1 Security risk analysis process
4.2 Intended use and identification of characteristics related to the security of the medical device
24 4.3 Identification of threats, vulnerabilities, assets, and adverse impacts
4.3.1 Identification of threats
4.3.2 Identification of vulnerabilities
25 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
26 5 Security risk evaluation
6 Risk control
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
27 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
28 8 Security risk management report
9 Production and post-production information
30 Annex A, Security engineering principles and nomenclature
A.1 Overview
31 A.2 Uniqueness of embedded medical systems
32 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
33 A.5 Considerations for emergency access
A.6 Medical device security architecture considerations
35 Annex B, Security risk assessment
B.1 Risk assessment process
36 Figure B.1 – A basic high-level risk assessment process
B.1.1 Prepare for assessment
37 B.1.2 Conduct assessment
B.1.3 Communicate results
B.1.4 Maintain assessment
B.1.5 Other security risk assessment processes
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
38 B.2 Risk model
40 B.2.1 Threat assessment
B.2.1.1 Characteristics of adversarial threats
42 B.2.1.2 Threat events
43 B.2.1.3 Example threats
B.2.2 Vulnerability assessment
44 B.2.2.1 Example vulnerability classes
45 B.2.3 Impact assessment
B.2.3.1 Asset inventory
46 B.2.3.2 Asset identification
47 B.3 Assessment approaches
B.4 Security analysis approaches
49 B.5 Assessing security risk
51 Annex C, Generating cybersecurity requirements
53 Annex D, Questions that can be used to identify medical device security characteristics
D.1 Essential performance
54 D.2 Data storage
D.2.1 PII/Private data assets
55 D.2.2 Non-PII data assets
D.3 Data transfer
56 D.4 Authentication & authorization
57 D.5 Auditing
58 D.6 Physical security
59 D.7 Device/system updates
60 D.8 Hardening
61 D.9 Emergency access
D.10 Malware/virus protection
62 D.11 Backup/disaster recovery
D.12 Labeling
63 Annex E, Security risk examples applied to a medical device
E.1 The Kidneato System
64 Figure E.1- Block diagram of the Kidneato system, managed environment
65 Figure E.2 – Block diagram of the Kidneato system, patient environment
66 E.2 Kidneato programmer
67 E.3 In-home monitor (IHM)
E.4 Web services
68 E.5 Web services – Direct access
69 E.6 Web services – Instrument access
E.7 Example implementations
E.7.1 Example #1 Basic Cyber Hygiene
70 E.7.1.1 Security analysis
E.7.1.2 Security risk evaluation
Table E.1 – Security risk evaluation table
73 E.7.2 Example #2 Implant Communications
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
74 Table E.2 – Risk estimation analysis example
E.7.2.6 Implemented control
E.7.2.7 Residual risk estimation
Table E.3 – Residual risk estimation analysis example
E.7.2.8 New risk identification
75 E.7.3 Example #3 WCA Firmware Update
E.7.3.1 Initial Design
E.7.3.2 Attack of the Design
76 E.7.3.3 Results from the Attack
E.7.3.4 Analysis
78 E.7.3.5 Security Risk Controls
79 Annex F, A comparison of terminology between key referenced standards
Table F.1 – Related terms in security standards/technical reports
82 Bibliography

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AAMI TIR5 2016 R2023
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