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Digital Health Review Process

By January 26, 2020 March 3rd, 2020 No Comments

When integrating a mobile technology into a clinical research study, an internal Digital Health Review (DHR) is typically conducted. This includes:  

Homegrown smartphone apps or wearables to be potentially marketed broadly, or via partnerships with a third party (software or mobile device creators, software engineers developing digital phenotype software, smartphone app developers) 

Use of marketed and readily available apps or other software in the clinical research context, including wearables (Fitbit, other sensors worn on the body), smartphone apps that passively collect data, installation of monitors that use wireless, Bluetooth or other methods to create information about an individual over time 

A mobile application, either under development or commercially available (including surveys), administered on a mobile device such as a smartphone, tablet or laptop 

A mobile application, either under development or commercially available (including surveys), administered on a mobile device such as a smartphone, tablet or laptop 

A touchable or wearable technology that is gathering physiologic and/or health data 

Technology that transmits data or communicates via Bluetooth or wireless technology 

Below are tips to accelerate this process and links to detailed resources. 

What information will I need for a DHR?

  • This link contains checklist for the review in the “What information is needed for a Digital Health Technology review? What if I just have an idea?” section. 
  • This section includes a sample form and example documents as well as other details about what how and what to prepare before calling the Digital Health Technology review team.  

Information needed will include: 

  • A description of the use case 
  • Answers to technology questions 
  • Contact Information for key developers or vendors 
  • All agreements 
  • Technology manuals 

How long will the review take? When does it happen in relation to IRB submission?

  • Allow extra time and ensure you have all of the technical information required before submitting to the DHR or to the IRB, as outlined in the timeline section.   
  • Attach all relevant documents within Insight before submitting.  This includes but is not limited to all technical documents related to data flow and security, manuals, End User License Agreements (EULAs), among others.  Each reviewer has their own timeline and review process as covered in the timeline section. 

How do I request a review? Who will be managing this review?

  • The Mobile Application Process Coordinator (MAPC)within the Partners HealthCare Research Information Science and Computing (RISC) office, helps the study team navigate this process by connecting them to the right people and ensuring they know what steps to take to address issues. 
  • The webpage contains information on how to request a review. 

How do I secure devices for use in my study?

  • Mobile Device Management (MDM) is a system that allows you to manage and encrypt devices.   PHS guidelines stipulate that all PHS owned devices are to be enrolled in our enterprise wide used MDM solution, which provides the required encryption and device management.  Best practice is to acquire devices through the PHS provisioning process. 
  • If you want to purchase any device, it is important to carefully consider where you acquire it from. The setup can take longer if it is acquired externally and/or provided by sponsor or a vendor.  
  • If you’re planning to utilize a non PHS managed laptop, it needs to be set up with the proper controls, as outlined on the MAPC webpage 
  • The MAPC web page contains resources and guidelines for securing devices in the “Provisioning and configuring new devices” section.  

I have a few other questions. Where do I go?

The Digital Health Review page provides answers to frequently asked questions (for example, how to speed up the review process and where to get support for setting up devices). This can be found in the “Digital Health Review FAQs” section. 

More Resources

  • Please click on the link to the Digital Health Review page to access helpful information 
  • You must be a Partners HealthCare employee to access the links below on this page.
  • Requests for information can also be sent to IRBDigitalhealthreview@partners.org 
Author Details
Founded in 2018, the Center for Innovation in Digital HealthCare serves as catalyst to promote the entrepreneurial and research-minded digital health ecosystem at Massachusetts General Hospital. It provides operational and advisory support to internal innovators and outside industry seeking to collaborate on digital health initiatives.
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Founded in 2018, the Center for Innovation in Digital HealthCare serves as catalyst to promote the entrepreneurial and research-minded digital health ecosystem at Massachusetts General Hospital. It provides operational and advisory support to internal innovators and outside industry seeking to collaborate on digital health initiatives.
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