COVID-19 Diagnostics Design-a-thon

Interpret-COVID Consumer Dx Test App

The FDA recently authorized the first Covid Dx test conducted completely at home by consumers. Our App provides the public with FDA authorized, pre-market information on rapidly emerging direct-to-consumer (DTC) tests and gathers feedback for post-market analysis. Consumers are empowered to own, collect, track or share test results with their physician. The App is built on a patent-pending blockchain platform that collects feedback from individuals via anonymous surveys. Survey questions will be designed to collect information from individuals regarding the performance of specific tests, clinical outcomes and other public health determinants. For example, analysis of data aggregates from these surveys will provide important information regarding the validity of specific tests, PPV/NPV, duration of vaccine immunity, correlations with demographics/social determinants/comorbidities, etc. User ability to track their test results over time via the App provides an important feature to gather longitudinal data. The App will have a feature to scan the UDI or barcode to authenticate each device. Data collected using blockchain technology bypasses the extant non-interoperable, siloed, centralized and non-secure internet-based systems. This consumer data will be directly funneled into the WATERS database to complement datasets collected via EHRs and labs, providing valuable insight on DTC tests data that otherwise would be missed.

5 min Video of Capstone Project

Elevator Pitch

Our App disseminates FDA authorized Covid Dx test information to consumers & collects outcome data via blockchain for post-market analysis.

Challenge Goals

Our prototype achieves both goals of the challenge. First, working with the FDA, we disseminate authorized DTC pre-market Coronavirus testing information to consumers and empower them to own, collect and track their test results over time and share it with their physician. Second, deploying anonymous consumer post-market surveys, we gather feedback on these tests and other relevant determinants that are useful to understand the Coronavirus pandemic. Decentralized, immutable and anonymous survey data, seamlessly collected via our App, will be blockchain encrypted and securely stored on the cloud, which can be directly funneled to the WATERS database for outcome analysis.   

Feasibility

We have engineered a prototype; the phases and the current status are as follows:

  1. Scrape the FDA database for consumer Diagnostic tests and relevant information (already done; need feedback)
  2. Create a consumer searchable database of FDA-authorized consumer tests (already done; need feedback)
  3. Barcode/UDI scanner and reader for App (to be done, 2-3 weeks, concurrent)
  4. Design questionnaire (already done; need feedback)
  5. Build database for capturing survey data, blockchain encryption, storage and transfer to WATERS (to be done 2-3 Weeks; can be done in parallel) 

With help from the FDA and HHS, we envision completing the project between 3-4 weeks depending on the level of support we receive. 

Design

The user interface was designed to be intuitive and user-friendly so that the average user can use it without any training. It is built to be able to support multiple languages (English and Spanish).

The pre-market information disseminated via the system is intentionally limited to sources such as fda.gov and hhs.gov. The system will not collect or track or any personally identifiable data. The survey results will be encrypted and stored in a blockchain. Blockchain usage will ensure that the data is secure and cannot be modified after submission. 

The App is designed to support offline usage in the future, so that it can be used in areas with no Internet connectivity. 

Innovation

Our game-changing blockchain platform addresses the major weaknesses in the current system to securely exchange health data. Using a decentralized, immutable and interoperable system, we create a seamless structure that does not require any of the current cumbersome infrastructure to securely capture and transfer data while ensuring consumer privacy. Similar systems have been used in the financial sector for years, executing billions of transactions. Healthcare has lagged behind in adapting to the digital age; for this COVID crisis and beyond, implementing tools such as ours that are scalable and easily accessible to consumers worldwide, the FDA can reach global populations to effectively regulate pre- and post-market consumer Dx tests.

Flexibility & Scalability

The App is compatible with iOS and Android as well as any standard browsers. Using blockchain technology we have created a decentralized, immutable platform that can capture and transfer consumer data securely. This anonymized data will be encrypted, stored in a blockchain and transferred to the WATERS database for data mining and analysis. The system is hosted in a global cloud platform that can scale with usage. We have flexibility to port it to a federal cloud platform if required. The blockchain used is similar to the one used by HHS. The system can be configured to work with other blockchains as needed. An API can be made available to enable other authorized systems to access data. 

Sustainability & Extensibility

Prior to this crisis, we were building a platform to validate genomic tests using a similar concept. We plan to create several diseases-specific platforms based on our prototype and disseminate up-to-date, expert-validated information needed by both physicians and patients. Our platform has a feedback mechanism to collect data on tests and clinical outcomes. Using AI, aggregated data will be analyzed to ascertain analytical and clinical validity, and clinical utility. With the rapidly expanding and evolving market of novel Dx tests, it is increasingly critical to disseminate reliable information to consumers and enable them to provide feedback. Our straightforward App fulfills both these needs

Team & Collaboration

Siromi Gardina PhD, MPH: Academic, regulatory & public health expertise at Harvard University, FDA and Brookings Institution. Relevant work includes pre- and post-market regulation of in-vitro diagnostics at FDA & directing research for the roadmap for ‚ÄúImplementing Unique Device Identifiers across the National Healthcare IT Infrastructure‚ÄĚ at Brookings Institution¬†

Himansu Karunadasa: Worked in the software space for the last 25 years co-founding 3 successful companies. Software developed are used by Oracle, AT&T, DELL, Monsanto, Johnson & Johnson, etc. Specialty is creating mathematical models and algorithms that can be implemented in software. 

Cynthia Stein MD, MPH: Physician, medical educator, Asst. Prof. at Harvard Medical School

Additional Comments

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What Team(s) contributed to this Capstone Project?

Interpret-Covid

If you are using patient data, are you using real patient data or mock data? Please use MOCK patient data only

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Sophia B Liu 1 month ago

This idea has been advanced to the current phase

People's Choice Voting Extended

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Sophia B Liu 1 month ago

This idea has been advanced to the next phase

People's Choice Voting Extended

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jool_petang 1 month ago

Amazing

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Moofi 1 month ago

very good

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Andrea Pitkus 1 month ago

Trying to understand if there are preconditions met by other software. (In general) 1. How to collect AOEs, from ordering provider/patient/specimen collector 2. Integrate into app/LIS or other information source for patient to be married to results of IVD test device/system 3. All transmitted to public health (ELR) 4. All transmitted to HHS (may be met by 3).

Will your approach support all 4 or only portions of above for "tracking lab results"? (Looks like the you are able to collect 1, but you have determined them and unclear if they include the HHS required elements?)

Do you support LIS based reporting of ELR in HL7 v2.51 (per the MU IG)? For patient performed results are they routed to the physician who is required to report via electronic Case Reporting (eCR) by law? How would your approach support LISs or labs that don't have API functionality?

Are LOINC, SNOMED CT and other codes systems supported at the point of origin or downstream as in your diagram to meet requirements?


How are CLIA testing requirements met in your system?

Curious about how your approach would "automatically" collect patient performed test results like the recent Lucira EUA? How about for Antigen or Antibody card (like pregnancy tests). How are result values read and assigned appropriate LOINC and SNOMED CT codes depending on the results/values for appropriate transmission to the provider and public health? How are AOEs and other patient provided info married with results before required reporting?

While it's true, Quest, LabCorp,, Costco and other laboratories/entities have patient COVID specimen collection kits that are sent to a CLIA lab for performance and reporting of testing, how would your approach work with Lucira as the only EUA for patient performed testing?

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