RESOURCES
- Privacy Guidelines
- Informed Consent to Participate in Research
- Health Information across all disease areas
- Pre-build Templates
- Innovations using Artificial Intelligence
Note: the resources here are gathered for convenience. They are not officially endorsed by Regeneron.
Privacy Guidelines
Health Tech Innovators brought to you by Regeneron is a US-only challenge, and as an entrant you will need to attest that you have satisfied the privacy requirements for the United States. Below we have summarized some key considerations to consider when developing your privacy notice:
FTC and State Privacy Requirements:
At a minimum, your privacy notice should include:
- Introduction
- What Personal Data is collected:
- This section would specify what personal data is collected and how it is collected (actively, passively, etc.)
- This section will also specifically note the sensitive personal data collected (i.e., health data) under state privacy laws.
- How is the Personal Data used:
- This section will specify the uses of personal data, including using the Personal Data to inform participants of future clinical trials.
- Who you will share the Personal Data with:
- This section will include any third party the data may be shared with and must specifically list Regeneron Pharmaceuticals Inc. as a party that would receive an individual’s de-identified data.
- How is the Personal Data stored/secured:
- This section will include details regarding encryption, data retention and any other security provisions.
- Data Subject Rights:
- This section would notify individuals of their rights under relevant data privacy laws and how to exercise those rights.
- If cookies are utilized, a section on Cookie usage:
- If cookies are used, this section would specify what types of cookies and advise individuals on how to manage cookies.
Please also review the FTC’s page on privacy requirements: Protecting Consumer Privacy and Security | Federal Trade Commission (ftc.gov). There are also several state privacy laws which may be applicable to your mobile application, including California, Connecticut, Colorado, Virginia, and Utah. These states have specific privacy notice requirements as well as specific requirements regarding collecting sensitive health data.
Does HIPAA apply?
We also recommend that you review the FTC’s Mobile Health App Interactive Tool, available at Mobile Health App Interactive Tool | Federal Trade Commission (ftc.gov). This will help you determine if you are a Business Associate under HIPAA and if the HIPAA Security Rule, HIPAA Privacy Rule and Breach Notification Rules apply to your mobile application.
If so, you will need to comply with those rules and confirm that the HIPAA patient authorization you collect allows for information that is de-identified in accordance with HIPAA to potentially be shared with Regeneron.
Informed Consent to Participate in Research
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.
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 a thorough review of protected health information and how to handle data.
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.
Health Information across all disease areas
MedlinePlus - Health Information from the National Library of Medicine
MedlinePlus is an online health information resource for patients and their families and friends. It is a service of the National Library of Medicine (NLM), the world's largest medical library, which is part of the National Institutes of Health (NIH).
Pre-build Templates
There are many useful resources to save time as you develop your innovation. Below, please familiarize yourself with the open-source tools and frameworks that you can build upon as you take on this Challenge!
Open-source ecosystem of many different modules based on international health data standards such as the HL7 Fast Healthcare Interoperability Resources (FHIR). Spezi can aid in rapid development of modern health applications.
A web application that allows you to build healthcare surveys using the HL7 FHIR Questionnaire international data standard using an interactive, drag-and-drop interface. May help with screening or onboarding tasks.
The HealthKitOnFHIR 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.
ResearchKitOnFHIR is 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. Similar to Phoenix, above.
5) Open Health Stack by Google
Provides building blocks for creating next-gen healthcare apps. Save time and make it easier to adopt modern healthcare standards (HL7 FHIR), leading to secure, offline-capable, data-driven solutions.
Includes a collection of open source technologies and open access design, technical, and implementer resources that help you build and deploy digital tools for community health.
Public domain suite of interoperable software tools designed for the global community of public health practitioners and researchers. It provides for easy data entry, construction, and analysis with statistics, maps, and graphs.
Q-Consultation Lite is offered free to developers wanting to create a virtual meeting room application with video calling, live chat, user management features, and integrated with OpenAI.
Innovations using Artificial Intelligence
If your innovation incorporates AI, the following resources may be helpful.
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.
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.
