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Use of real-world data (RWD) to enhance research efficiency and bridge evidentiary gap between clinical research and practice

  • Increasing accessibility of digital health data
  • Transition to electronic health records (EHRs)
  • Address rising costs and recognized limitations of traditional trials
  • Research collaborations with Flatiron Health and CancerLinQ for big oncology data
  • Need access to other large databases

FDA effort should be supported by CMS’ Blue Button 2.0 – see below

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CaptureKeynote speaker, CMS Administrator Seema Verma, on  Blue Button 2.0 and the MyHealthEData initiative

  • Developers use Medicare claims data to facilitate cost-effective care
  • Aggregate genetic information, medical records, claims data and wearable data in one electronic health record people can share with doctors and researchers.
  • Release of Medicare Advantage data to speed interoperability between EHRs and PHRs
  • Plans to release Medicaid data next year
  • Among 600 companies partnering on Blue Button 2.0 initiative are Verily Life Sciences, Rush, Humetrix, Health Endeavors, Anthem, Massachusetts Institute of Technology, 23andMe, Medware, 3K Technologies

Blue Button


Capture.JPGTech Companies Joint Commitment to Improve Healthcare Data Interoperability

Amazon, Google, IBM, Microsoft, Oracle, Salesforce

  • Frictionless exchange of healthcare data
  • Open standards, open specifications, and open source tools
  • Actively engaging among open source and open standards
    communities

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FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

Potassium chloride oral solution USP

Apotex Inc

Several strengths of potassium chloride oral solution approved via  Competitive Generic Therapy (CGT) designation

  • New approval pathway
  • Expedite development and review of generic drug that lack competition

INDICATION: Treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible

EFFICACY, SAFETY, QUALITY

  • Met approval standards that ensure an equivalent, high quality, safe and effective generic medicine
  • Review of manufacturing and packaging facilities

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Image credits: JAMA, FDA. CMS

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