Ohio passes Medicaid reimbursement for telehealth; CDS regulation

By Brian Dolan
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Brian Dolan, Editor, MobiHealthNewsAARP seeks health startups for LivePitch event in Boston: AARP is hosting an event in Boston in May that will include an Innovation@50+ LivePitch session for digital health startups focused on the "50 and over" population. The event is looking for both very early stage startups in the "concept phase" as well as those that are a bit further along and have raised money but not more than $5 million. Email me if interested.

CardioNet-based mobile health startup plans take-home iPad pilot: Lawrenceville, Pennsylvania-based Wellbridge Health, which has funding from BioTelemetry -- formerly called CardioNet -- is planning a spring rollout for a pilot of its iPad-based patient tracking system aimed reducing unnecessary readmissions for heart disease patients. BioTelemetry, one of the few publicly traded digital health companies, offers a wireless-enabled heart monitor and service. Wellbridge offers patients an iPad along with easy-to-understand instructions to keep track of the health of congestive heart disease patients recently released from the hospital after an episode. In late 2012 when it was still called CardioNet, BioTelemetry offered up its own iPad app for physicians treating heart patients.

Ohio state telehealth reimbursement bill passes: A bill unanimously passed Ohio's Senate last week that requires the Department of Medicaid to establish Medicaid reimbursement payment standards for telehealth services in Ohio. The bill still needs to be signed by the governor to become law. Ohio-based HealthSpot, which offers biometric device-equipped health kiosks, backed the bill.

Thoughts on the regulation of CDS software: Regulating clinical decision support is thought to be one of the next areas that the FDA is expected to turn its attention following its final guidance on mobile medical apps last year. According to a recent legislative position paper developed by the Clinical Decision Support Coalition -- a group that has some overlap with the mHealth Regulaory Coalition -- the FDA should only regulate CDS if all of the following are true:

"1. The intended use of the software provides a diagnosis of a serious or life threatening disease or other such condition, or directs a specific cure, mitigation, treatment, or prevention of such disease;

"2. The intended user of the software is expected to be substantially dependent on the software for the diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease. Substantial dependence means: a. the intended user is not trained or otherwise qualified to make the decision without the use of the software; b. the software does not disclose to the intended user, in sufficient detail for the intended user to make an informed, independent decision, the patient-specific information, the clinical content on which the analysis is based, the output, and the underlying clinical rationale for the output; or c. the intended use environment does not allow the user sufficient time to evaluate and consider the output before acting on that output; and

"3. The software meets such other criteria as the Secretary shall specify by regulation to promote innovation while protecting patient safety."

Passive fitness tracking app Human adds indoor activity tracking: "The goal is to move for 30 minutes every day, and to keep up with this simple habit. The company calls it the ‘Daily 30′. As it is extremely simple, keeping up with Human is easier than with competitive fitness systems," Techcrunch reports.