Discovery Use Case Hypotheses - SRA-18F-GSA-Agile-Services/checkFDA GitHub Wiki

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Goals of OpenFDA

  • Create easy access to public data
  • Create a new level of openness and accountability
  • Educate the public and save lives
  • Format and document that data in developer and consumer-friendly standards
  • Enable developers to quickly and easily use it in applications

Data Available

  • Adverse events - FDA’s publically available drug adverse event and medication error reports, and medical device adverse event reports.
  • Recalls - Enforcement report data, containing information gathered from public notices about certain recalls of FDA-regulated products.
  • Labelling - Structured Product Labeling (SPL) data for FDA-regulated human prescription drug, OTC drug and biological product labeling.

Potential User Types

  • Patients (ex: with chronic condition)
  • Caregivers (ex: of elderly parent or parents of minors)
  • Physicians and nurses
  • Pharmacist
  • Lawyer
  • Medical Researcher
  • Medical Instructor
  • Health Care System
  • Health Care Plan

Use Case Hypotheses by User Type

Patient
  • I was just diagnosed and have several medication options for treatment
  • I am on several medications for ongoing clinical depression
  • I think I’m experiencing some side effects with my but want to learn more before talking with my doctor about them
  • I heard something on twitter about a potential recall and I want to learn more
Caregiver
  • I’m taking care of my aging parent who is taking several medications
  • My child has severe allergies and I need to know about everything
  • I’m getting my child vaccinated
Physician
  • My patients seem to be complaining about a side effect of their medication but I’m not sure if this is just a coincidence, or if other patients are experiencing the same thing.
  • I want to make sure I have the most up-to-date, accurate information to tell my patients about medications and medical devices.
Hospital/Healthcare System/Medical or Nursing School
  • I want to know the overall risk profile of a drug or medical device so we can train our care providers with the most up-to-date information.
  • I want to improve our education and training program.
Researcher
  • I want to test a hypothesis around adverse events for drug options for a particular condition.
  • I want to further research about what types of drugs and devices have a higher risk to harm patients.
Businesses partners that want to meet consumer needs:

  • I’m a community platform (patientslikeme) and want to create a 2-way street where our online community provides the FDA with adverse event information and we are able to surface that information back to the community population.

  • I’m a large pharmacy (Walgreens) and want to create a platform for our consumers to search for medication-related information.

  • I’m a food app (Edibly) and want to help my users to see the inactive ingredients in mediations easily.

  • I’m a decision support tool (WebMD) and want to add a layer of information to help our customers make decisions around drugs and medical devices.