1 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Tim McKay Mobile Health Workgroup April 6, 2015 Consumer Mobile Health Application Functional Framework: An Introduction

2 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Why start this project?  Need for criteria to enable development of consumer health apps which have a uniform approach to security, privacy and data use  Current HL7 functional models cannot be used as-is to allow for certification of secure consumer-facing mobile health applications  Shift in consumer health offerings from being o Global in scope and Web by channel to o Narrow in scope and Mobile by channel  Provide a path for the certification of apps o Consumer confidence o Provider confidence

3 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off In Scope  This project will define security, privacy and data standards for secure mobile health applications (apps) o Limited to smartphones but may be extended to tablets o Standards will cover the app lifecycle  Central artifact is a set of conformance criteria (functional requirements) o Conformance criteria address the key user stories of the human actors of the system. o Conformance criteria address the technical actors necessary to fulfill the stories of the human actors

4 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off In Scope Conformance Criteria Topics  Privacy policy, terms of use, and in-app disclaimers  User, device, and cross-system authentication  Authorization to content and features  Proxy designations  Use of location services, camera, accelerometers and other smartphone services  Security of data at rest (local and cloud)  Security of data in transit (wired and wireless)  Minimum data standards for device generated and device transmitted information  Record system reliability; record authenticity  Data provenance  Audit  Standards related to discontinuation of use of an app

5 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Key Actors HumanNon-human App User Clinician Family Caregiver App Developer Third-Party Data Aggregator Regulator Mobile Health App Smartphone App Store Data Collection Device External Data Repository EHR System PHR System Social Media Site

6 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Examples of User Stories App UserClinicianApp Developer I want my access to the app to be secure. I want to control access to who can view or use any data generated from the app. I care about some data a lot; other data I really don’t care about. I want the app to potentially improve my health and wellbeing. I do not want the app to harm my health and wellbeing. If I stop using the app, I want to be able to determine what happens to any data stored by the app. If I am allowed to use data generated from the app, I want to know enough about the data to determine if I can trust using it in making decisions about clinical care. I want the app to potentially improve the health of my patients who use it. I want the app to potentially improve my relationships with my patients who use it. I want the app to not overstep its bounds in terms of clinical claims. I want the app to be widely used. I want the app to potentially improve the health of its users. I do not want the app to harm the health of its users. I want to comply with known laws and regulations to that: 1) my company does not become subject to regulatory oversight; 2) my app can be used as widely as possible. I want my company to make money from the app.

7 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Mobile app lifecycle

8 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Out of Scope  This project will NOT define standards for the content of mobile applications.  This project will NOT address apps written for basic phones.

9 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Approach 1 of 3 Conformance criteria already available within the HL7 PHR-S and EHR-S Functional Models will be reused, augmenting the framework with new conformance criteria specific to mobile platforms (device, context and user characteristics). Glossary terms and verb hierarchies of the PHR-S and EHR-S will be reused. DeviceContextUser Text messaging Camera & microphone Geolocation Accelerometer Near Field Communications Device reliability Continuous data collection PHI and PHII contained on devices Unique device ID Attached data collection devices Calendar and Address Book App use anywhere anytime Environmental conditions Bandwidth Lost devices Generational usage patterns User disabilities Social media sharing

10 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Approach 2 of 3 Speed to market is valued more than a 100% complete model  Target: have draft ready for comment-only ballot for September Use comments to address significant gaps to prepare for DSTU ballot for May  80% rule: at this stage of development, conformance criteria address most issues of relevance for most apps  Emphasis on “shall” and “should” criteria over “may” criteria

11 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Approach 3 of 3 Publishing format is TBD, but should consider a structure which facilitates standards-conformant product development  Conformance criteria applicable to all apps  Conformance criteria conditionally applicable to some apps  Easy to convert conformance criteria to product requirements  Within standard be able to reference workflow diagrams, exemplary use cases/user stories, enabling standards and FHIR ® resources applicable to fulfilling conformance criteria  Ability to publish updates which are accessible before formal ballot Consider organization based on app lifecycle from the point of view of the primary user of the app

12 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Document Organization by App Lifecycle Pre-Market Regulatory/Compliance Approval Determine need for approval(s) Obtain approval(s) Complete Risk/Security Assessment Search for & Download App Description of App in App Store Access to Terms of Use Access to Privacy Policy Launch App/Establish User Account Acceptance of Terms of Use Account Creation Identity proofing of account holder Account linking to pre-existing information Establish mechanisms for user authentication Use App Session security User authentication User authorization Session encryption Device/Smartphone Pairing Authorization of Data Collection Data content Use App (continued) Method of collection Smartphone capabilities data (e.g., calendar, contacts) hardware (e.g. camera, location) External device Associate Account with External Systems First pairing Ongoing authentication/authorization Account disassociation Data Storage Data security Device storage Cloud/external storage Data authenticity Data provenance Data Transmission Ability to transmit stored data Standards-based data transmission Authorization by user Single authorization Subscription authorization Data formats Unstructured data Structured data biometric data code sets Use App (continued) Metadata user device biometric Authorization of Third Party Access/Use Account proxies External actors Human System Sign-out From App Data Deletion Permitted/Prohibited 3 rd Party Uses Notifications and Alerts Upgrade App to New Version App Usability Audit Delete App App Removal Data Removal Smartphone Cloud Data Relocation Permitted/Prohibited uses of data post account closure

13 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Work Plan  Gain consensus on scope and approach  Draft a structure for organizing conformance criteria  Identify criteria for re-use from PHR-S FM and EHR-S FM  Select and harmonize PHR/EHR criteria  Add new criteria to model which address mobile-specific issues  Harmonize criteria against glossary and verb hierarchies  Complete narrative text  By August 1, complete initial draft of framework to submit for September comment-only ballot

14 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Discussion

15 © Health Level Seven International ®, Inc. All Rights Reserved. HL7 International and Health Level Seven International are registered trademarks of Health Level Seven International, Inc. Reg. U.S. Pat & TM Off Project and contact information Meetings: Standing meetings are on Mondays at 2 PM Pacific (5 PM Eastern)  WebEx: 4a13407f4aa8a0dc2f 4a13407f4aa8a0dc2f  Phone: Passcode: **A face-to-face meeting will be held in Oakland, CA on April 27/28. See Wiki for details and to RSVP Wiki: cation_Functional_Framework, cation_Functional_Framework Project Lead: Tim McKay,