Saturday, June 20, 2015

#CHSD15 Kim Tyler-Knott – The Regulatory Rocking Chair

connected Health 2015

Realtime notes from Day 2 of ConnectedHealth 2015 in San Diego #CHSD15.

Kim Tyrrell-Knott, Partner, Epstein Becker and Green

FDA regulation of Clinical Decision Support happens today.

  • Information
  • Conversion
  • Clinical Decision

Take in data. Evaluate and then make patient-specific actionable recommendations.

FDA focus on:

  • High risk decision support
  • Computer-aided detection/diagnostics
  • Remote display/notification of real-time alarms
  • Radiation treatment planning
  • Robotic Surgical Planning and control
  • Electrocardiography analytical software.

New Reality: Health and Device industries under attack

Malicious attackers are targeting healthcare related systems including Medical Devices. This includes targeting intellectual property and development data from manufacturers.

Medical Devices are impacted by:

  • HIPAA Privacy Rule
  • HIPAA Security Rule
  • State Law
  • FTC
  • FDA Guidance (Cyber security issues that they care about)

Federal focus on Cyber Security. Cyber attacks as National Security, economic and safety issue

State: NY proposed Data Breach Law. Allow third party audits and certifications to offer rebuttable presumption of reasonable data security.

FTC – Privacy enforcement is top priority

A lot of health data that is not covered by HIPAA.

FDA: Cybersecurity – what are risks to patients.

Telemedicine Reimbursement:
Medicare Chronic Condition Management – $42 per patient/month

Still a preference for real time over store and forward.

Medicaid has a different framework and is more forgiving than Medicare. Also look at private Payers.

[category News, Health]

[tag health cloud, bluebutton]

Mark Scrimshire

IT and Health Data Ninja

Mark is available for challenging assignments at the intersection of Health and Technology using Big Data, Mobile and Cloud Technologies. If you need help to move, or create, your health applications in the cloud let’s talk.
Stay up-to-date: Twitter @ekivemark


I am currently HHS Entrepreneur-in-Residence working on an assignment to update BlueButton for Medicare Beneficiaries. This involves creating a Data API. Watch out for more about BlueButton on FHIR.

The views expressed on this blog are my own.

I am also a Patient Engagement Advisor, CTO and Co-Founder to Medyear is a powerful free tool that helps you collect, organize and securely share health information, however you want. Manage your own health records today.

Medyear: Less Hassle, Better Care.

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