ALL TRACKS: Helpful Links for Informed Consent and Template Resources

Hello Innovators! This is the main discussion board for patients, providers, researchers, developers, and all health tech stakeholders to share informed consent insights and useful application templates.

*If your innovation collects patient data, you are required to review the following links with suggested language regarding informed consent:

1) FDA Guidance for Electronic Informed Consent
Official guidance document that details the process of consent, and how to adapt consent to an electronic format if needed. Includes consenting overview and expectations for researchers collecting data. https://www.fda.gov/media/116850/download

2) UCSF Human Research Protection Program
University of California San Francisco has plenty of pre-built templates for consent language and HIPAA authorization. This resource also includes thorough review of protected health information and how to handle data. https://irb.ucsf.edu/hipaa

3) UW Human Subjects Division
University of Washington has prepared materials for all researchers conducting studies requiring participant consent. You will find information on how to appropriately collect consent, and templates to suit your innovation’s needs. https://www.washington.edu/research/hsd/guidance/consent

*Additionally, here are a few open source modules that may accelerate your development timeline:

1) HealthKitOnFHIR
This library provides extensions that convert supported HealthKit samples to corresponding FHIR resources using FHIRModels. Useful when building for Apple devices and operating within the Swift ecosystem. https://github.com/StanfordBDHG/HealthKitOnFHIR

2) ResearchKitonFHIR
A framework that allows you to use FHIR Questionnaires with ResearchKit to create healthcare surveys on iOS based on the HL7 Structured Data Capture Implementation Guide. https://github.com/StanfordBDHG/ResearchKitOnFHIR

*If your innovation incorporates AI, please check out the following resources which may help you:

1) LLM on FHIR - Demystifying Health Records
This repository contains the LLM on FHIR Application to demonstrate the power of LLMs to explain and provide helpful context around patient data provided in the FHIR format. May help with inspecting, summarizing, and interpreting data. https://github.com/StanfordBDHG/LLMonFHIR

2) HealthGPT
HealthGPT is an experimental iOS app that allows users to interact with their health data stored in the Apple Health app using natural language. The application offers an easy-to-extend solution for LLM powered applications. https://github.com/StanfordBDHG/HealthGPT

3) Open Source by McKinsey
A collection of widely applicable platform tools to use in data science, MLOps, visualization, and analysis. Modules include Kedro, MLRun, Nuclio, Vizro, CausalNex, and QBStyles. https://github.com/mckinsey

*Finally, tell us about yourself and what you would like to see!