Patient Data and Regulatory: Which Hurdles still need to be cleared before Mainstream Adoption and Widespread Deployment?


October 8, 2015 -

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Alfred O’Neill

‌• How to maintain privacy and security for patients, providers and pharma – understanding the nuances, risks and challenges of patient data

‌• Business intelligence around patient data – utilization to impact outcomes

‌• Risk Management – Who is responsible for the device’s performance and QA? Pharma? The device manufacturer? CROs? Ensure compliance and manage risk

‌• Integration of ePRO and Mobile-PRO with other eSolutions to change the paradigm for the patient

‌• Take the necessary steps to ensure that your solution gets 510(K) approval from the FDA

‌• Regulation of mHealth devices and apps – is there an emerging best practice?

‌• How EHR standards are being addressed with wearables and data segmentation

‌• Overcoming hurdles around utilizing previously acquired and third party data integrations

‌• Interoperability hurdles and how to overcome them – avoiding data silos