Askew final project

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Askew final project

  1. 1. Mobile Medical Apps4/30/2013Dee Askew HIMA 5060 1
  2. 2.  Termed Wild West New industry: mHealth Minimum of regulation Also termed Revolution Many new apps Handheld hardware supported Smartphones Tablets Societal norm Apps for almost every aspect of life Extend human capabilities to manage life/time4/30/2013Dee Askew HIMA 5060 2
  3. 3.  Timely access to information Patients and Practitioners Greater patient involvement in self-care Data collection for research Researchers and Subjects Potential fraud detection Medicare and Medicaid4/30/2013Dee Askew HIMA 5060 3
  4. 4.  Being viewed as a gadget Privacy and confidentiality Being ineffective Hardware Software app Less than optimal environment Being harmful4/30/2013Dee Askew HIMA 5060 4
  5. 5.  Consumers in market Private companies Academic initiatives Medical associations Independent doctors/medical students Researchers Collaborative groups Health 2.0 TedMed4/30/2013Dee Askew HIMA 5060 5
  6. 6.  Food & Drug Administration Has 2011 draft guidelines in place FDA reviewed about 20 MMAs last year FDA has reviewed est. 100 MMAs in total Unclear processes & product specifications 510(k) exemption Accessories and parent devices Unclear regulatory authority● FDA ● ONC ● FCC ● FTC Federal Trade Commission enforcement ofapps making false health claims4/30/2013Dee Askew HIMA 5060 6
  7. 7.  Drive up costs of apps Delay product releases Export jobs abroad Suppress innovation and productivity Government regulation would be barrier toentry into the app market4/30/2013Dee Askew HIMA 5060 7
  8. 8.  Clarify regulatory process Clarify product classifications Define product quality and appropriate use Establish standards Require data security measures Protect people who may be mislead byincomplete or inaccurate information4/30/2013Dee Askew HIMA 5060 8
  9. 9.  Permit present environment to persist Permit collaborative groups to influenceoutcomes Academic initiatives / research articles Conferences like TedMed Lobby groups Permit medical community to endorse apps Permit FDASIA’s to study and provide reportfor Congress4/30/2013Dee Askew HIMA 5060 9
  10. 10.  Permit work group to study and report toCongress in 2014 Wait to Further Regulate Foster innovation and keep jobs/companies in US US legislates to prevent known problems Current Regulatory Efforts sufficient FTC should continue to police false claims FDA should continue to review riskier devices FCC should continue to monitor capacity Consumers evaluate and rate apps/devices4/30/2013Dee Askew HIMA 5060 10

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