New Continua Design Guidelines Support Health in the Home by Targeting Direct-to-Cloud Solutions

9 months ago

Jan 15, 2020

By Thom Erickson, MSBA, BSEE, Director, Technical Operations, PCHA and Adam Bazer, MPD, Senior Technical Manager, Interoperability and Standards, HIMSS,

It is easy in our weak moments, our shadow moments, those moments we don’t like to share, to feel disconnected from our communities, our families, our selves.  And at those moments when our health impacts our life, which is a nice way of saying when we acutely sense our mortality, it is incredibly easy to feel detached from those who care about us, and those who care for us.

It is hard in our strong moments, our shining moments, those moments we like to share, to connect the disconnected, sense our mortality with strength. It’s important to make certain personal health technologies make health and wellness an effortless part of daily life.

“To enable health for everyone, institutions and systems must be people-oriented and work to serve those who use them most” says Robert Havasy MS, Managing Director of the Personal Connected Health Alliance. “This release of the Continua Design Guidelines shows medical device manufacturers how to communicate personal generated health data to healthcare providers without the need for Bluetooth or WiFi pairing by the patient.”

A typical scenario of a direct-to-cloud deployment is a sensor (e.g. pulse oximeter, blood pressure monitor, glucose monitor) connecting via a cellular service provider to a cloud server. The device is pre-configured with sufficient information to know to which server it should attempt to communicate with before attempting to establish a connection.

“We’re excited to see the inclusion of a direct-to-cloud cellular-based approach in the latest release of the guidelines” says Jon Lee-Davey, IoT Global Healthcare Lead, Vodafone Business. “The direct-to-cloud approach inherits the enhanced security of our mobile networks, whilst offering patients and healthcare professionals a simple experience for deployment of, and data collection from, devices in connected health services.”

Once a secure connection is established, the guidelines applies the HL7 FHIR® standard to communicate sensor measurements to FHIR observation servers. This latest release reduces the complexity of the guidelines by directly referencing the FHIR Personal Health Data Implementation Guide developed by PCHA for HL7.

“PCHA creating the FHIR IG in HL7 consolidates industry standards. This is an essential key step in reducing industry confusion around data exchange standards and accelerating their adoption” says Grahame Grieve. FHIR Product Director for HL7.

Finally, this release of the guidelines references the normative release of the HL7 Personal Health Monitoring Report. This CDA-based standard enables the automated reporting to EHR systems of patient measurement data taken by consumer medical devices. The cost to implement this standard has been reduced by no longer requiring the use of SNOMED.

The PCHA develops commercial ready software that simplifies and accelerates implementation the Continua Design Guidelines. To streamline regulatory approvals, this software is developed in accordance with IEC 62304 under an ISO 13485-based quality plan.

While standards are essential, they are not sufficient to ensure multi-measurement interoperability. Going beyond the implementation guidance of the CDG, PCHA also provides tools and processes necessary to demonstrate products comply with applied standards and customer requirements. Demonstrated interoperability is also key to resolving root causes of regulatory challenges. Learn more about this assessment program and free test tools.

Integrate these personal connected health solutions into your products and reap the benefits of one implementation that can connect to a broad ecosystem of electronic health systems.

Engage with PCHA today.