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Health App Risk Assessment - Conformance Criteria
HL7 CMHAFF Sections
Categories
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1. Introduction
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2. Overview (2.0 - 2.3)
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2.4 Exemplary Use Cases
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2.5 Environmental Scan
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3. Conformance Criteria
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3.1 General Considerations
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3.2 Product Development
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3.2.1 Regulatory Considerations
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3.2.2 Product Risk
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3.2.3 Usability Assessment
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3.2.4 Technical Support
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3.3 Install App
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3.3.1 Product Information
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3.3.2 Launch App
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3.4 Use App
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3.4.1 Authentication
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3.4.2 User Authorization
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3.4.3 Pairing or Syncing
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3.4.4 Security for Data at Rest
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3.4.5 Security for Data in Transit
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3.4.6 Data Authenticity
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3.4.7 Data Exchange
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3.4.8 Notifications & Alerts
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3.4.9 Product Upgrades
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3.4.10 Audit
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3.5 App Termination
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3.5.1 App Data Removal
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3.5.2 Permitted Uses
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3.6 Nonfunctional Requirements
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3.6.1 Conditions & Agreements
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Risk Assessment Conformance Statements
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