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2.4 Exemplary Use Cases

As noted in the Introduction, consumer mobile heath apps take many forms, and as such, conformance statements in section 3 of this standard must allow for variation based on multiple factors, including data sensitivity, the nature of conditions addressed by the app (e.g., wellness, chronic illness), and whether/how app data connect to other data sources.

In this section, three archetypal use cases are introduced. While most consumer mobile health apps will not precisely fit any of these models, the models are meant to demonstrate a continuum of issues which may be applied to any app. Use Case A covers the least sensitive example of a health app that collects user information, while Use Case B builds off of Case A with the inclusion of an external system through which personal data is synchronized with the device. Use Case C is the most sophisticated and generates the most requirements. Its description includes examples of the risk factors that should be considered by developers and users.

Section 3 (Conformance Criteria) includes discussion of considerations as to how subsets of conformance criteria can be addressed in different manners, referencing the use cases in this section as a way to provide directional, rather than pinpoint, guidance.

HL7 CMHAFF Standard Overview and Use Cases

FDA Playbook on Medical Device Cybersecurity

Regional Incident Preparedness and Response Playbook

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From the MITRE website:

The Medical Device Cybersecurity Regional Incident Preparedness and Response Playbookoutlines a framework for health delivery organizations (HDOs) and other stakeholders to plan for and respond to cybersecurity incidents around medical devices, ensure effectiveness of devices, and protect patient safety.

The healthcare sector knows how to prepare for and respond to natural disasters. It is less prepared, however, to handle cybersecurity incidents, particularly those involving medical devices. Recent global cyber attacks highlighted the need for more robust cybersecurity preparedness to execute an enhanced, effective, real-time response that enables continuity of clinical operations.

Securing Electronic Health Records on Mobile Devices

Guidance from the National Institute of Standards and Technology (NIST) Special Publication: 1800-1

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Using mobile devices to store, process, and transmit patient information has become increasingly popular amongst healthcare providers. When health information is compromised, organizations can face penalties and lose consumer trust, and patient care and safety may be at risk.

To address this challenge, cybersecurity experts at the NCCoE collaborated with the healthcare industry and technology vendors to develop an example solution to show healthcare providers how they can secure electronic health records on mobile devices. The solution is guided by standards and best practices from NIST and others, including the Health Insurance Portability and Accountability Act (HIPAA) rules.

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