NIHPO is integrating Health Data sources across government agencies through a health-focused search engine.
We want to provide:
Estamos construyendo un motor de búsqueda de información de salud en Español. Nuestro sistema está diseñado para que usted haga preguntas en Español, y le daremos las respuestas también en Español.
Federal agencies in the health space (i.e. EPA, FDA, HHS, NIH) regularly release large datasets under several Open Data initiatives. Unfortunately, data related to a single topic (say, medical devices) are often scattered across agencies and within functional units of a single agency. Stakeholders wishing to use such topic-specific data (inventors; manufacturers; regulators; physicians / surgeons; buyers / hospitals / GPOs; patients; and payers) must integrate those datasets on their own.
NIHPO proposes to serve all stakeholders through the integration of data sources along topical areas, regardless of the agency that provides the underlying raw dataset. NIHPO is building a search engine for medical device data that integrates raw data from the FDA and HHS' OpenPayments.
Medical Devices are a very complex, multi-sided market: manufacturers design, build devices; regulators approve their sale; hospitals purchase them; surgeons install the device; payers cover the costs; and patients use or wear the device.
Medical devices also have a significant human impact: for example, in 2008, around 350,000 pacemakers and 140,000 ICDs were implanted in the US. Stakeholders in this market are surrounded by raw data but they're starved for actionable insight.
NIHPO's research premise is: "Can cross-linking disparate health data sources in a search engine lead to higher usability for all stakeholders?" NIHPO's search engine design and data representation model are optimized for the lay user, primarily senior citizens. And targets Spanish speakers as well.
Making health-related Open Data Findable, Accessible, Interoperable, and Reusable ("FAIR") required an innovative approach. NIHPO users benefit from better results, faster, leading to more efficient and effective decision-making.
Although the FDA has compiled medical device adverse event data since June 1993, the FDA's web-based searchable database only contains the last 10 year's data. And there's no alerting mechanism currently in place. NIHPO includes the entire FDA MAUDE dataset. With summaries of total events by manufacturer per year, or total number of deaths by device class. Users can subscribe to alerts by device, manufacturer name, or device class.
Medical device manufacturers oftentimes provide compensation (financial or otherwise) to healthcare providers ("HCPs"). Those payments are reported in the HHS' OpenPayments database. Users (patients, hospital buyers, attorneys, etc.) can leverage NIHPO to correlate a device's adverse event history against a particular HCP's recommendation, cross-linked with industry funding to the HCP. This wrap-around view can help surface potential conflicts of interest.
The FDA does not harmonize the names of the device manufacturers when adverse event reports are filed. Users have to search for potentially hundreds of name combinations of a manufacturer's name. "Depuy" alone has over 600 variations.
NIHPO manually curates and harmonizes manufacturer names, saving users' time and providing more accurate results.
The raw data sources (both FDA MAUDE and OpenPayments) are very dry and number-centric, for obvious reasons. NIHPO uses Social Math to turn individual records into a "story" that is both easy to digest and more actionable.
Each year, over 8,000 new medical devices are marketed in the United States, including 50-80 high-risk devices. Users can leverage NIHPO to:
NIHPO's easy-to-use interface has all the features users may need, easily accessible, in a simple and self-explanatory layout. Users know what to anticipate from each feature and where exactly each link will take them. NIHPO's website is purposefully minimalistic, with no distracting features.
Search results for an adverse report are presented as a story:
NIHPO built a proprietary algorithm to rate and rank medical devices' predicted risk factor. Using these data elements: number of reports over last 12, 06, 03 months; patient impact (injured, hospitalization required, death); rates for similar devices in same class; among others.
For example: a device with a high number of recently-reported incidents, and a few deaths, would be assigned a "High" risk rating.
This research and initial software development were self-funded. Additional funding is desired to scale up our integrative approach to health data search:
NIHPO has deep medical device, public health, database and software development experience. And NIHPO's founder has successfully developed, commercialized data services.
Please contact us if you would like to see a demo of our search engine.
Section 21 CFR 803.16 states that "A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event." In addition, some firms have submitted their own additional disclaimer statements. Source: FDA's MAUDE page.