The Continua Design Guidelines specify an end-to-end ICT framework for personal connected health solutions based on recognized open standards, to create a secure and interoperable health data exchange. They enable the secure flow of Continua medical-grade data among sensors, gateways, and services by providing clear guidance on their interoperability adding the necessary missing features within the underlying standards or specifications. And, to ensure interoperability, they offer a compliance and interoperability program to validate that devices interoperate with gateways and services.
What does Continua try to solve?
The world faces both the necessity and a unique opportunity to change the way healthcare is provided; from a hospital centric focus to a more consumer/patient centric, prevention and care management oriented approach through the appropriate use of information and technology.
Such an approach requires that health providers have both access to rich, relevant and reliable health data and the adequate tools to guide both them and their patients towards better decisions with the diagnosis, treatment and support within efficient workflows. The potential is widely recognized to enable greater health outcomes at lower long-term cost while providing greater consumer satisfaction.
While many hurdles exist, institutions are globally working to develop capabilities to meet these critical needs. The CDG’s aim to resolve one specific hurdle, namely the difficulties experienced by implementers who technically integrate solutions that support PCH devices and services. More specifically, the CDG’s fosters integration to enable medical-grade health/sensor data to flow from a multitude of vital signs devices used by consumers to health services, all the way into local, regional or national EHRs and data lakes in a safe and secure manner.
Why should market actors such as device vendors, system and health services providers bother?
Non-interoperability between the eco-system components is the central obstacle that prevents market actors to compose integral PCH solutions.
- Vital signs sensor vendors see their market segmented along different methods and technologies of communication with health service providers and the systems they use in their processes and business operation. They lose the non-recurring engineering (NRE) and throughput time to adjust their offerings to the varying and changing needs or must accept to be excluded from some market segments.
- PCH system providers face a similar issue: to connect to a multitude of sensors, they have to spend significant development resources and expertise to integrate and support the broad array of connectivity options.
- Health service providers face fragmentation of technology offerings. They have to pay system integrators to spend NRE and throughput time to make dissimilar system elements work together and in the specific environment. If instead they buy a vertically integrated solution from a single vendor, they are locked-in to the offerings of that particular vendor, and are limited to the functionalities offered by this vendor. Due to the difficulty for PCH system providers to create multi-measurement solutions suitable to manage a variety of health conditions, most available vertically integrated solutions only target a very narrow scope of care and offer only limited technology, e.g. using blood sugar level as the sole input to manage only diabetes. This mismatches the reality of most people suffering from co-morbidities.
- All players face regulatory hurdles when integrating PCH systems. The composed system must obey the rules for a Medical Device as much as its individual elements; however, in case where the integration is ad hoc rather than well planned, compliance is very hard to demonstrate for the system.
All of this results in unnecessary complexity of business partnering and in investment uncertainties. The involved efforts are wasted resources necessary to create bespoke interoperability and complex integration. Hassle free integration that unleashes the data is possible today.
How could Continua help resolve this?
The Continua Design Guidelines specify an end-to-end information and communication technology (ICT) framework for personal connected health solutions based on recognized open standards, to create a secure and interoperable health data exchange. They enable the secure flow of medical-grade data among sensors, gateways, and services by providing clear guidance on their interoperability by adding the necessary missing features within the underlying standards or specifications. The value that the CDG’s provide is secure medical data exchange fully harmonized with existing adopted healthcare standards and protocols understood by regulatory agencies, governments, EHRs, clinicians, etc.
The FDA has since long looked at the CDG’s as a tool to reduce the uncertainties about compliance of PCH systems with Medical Device regulations. Continua compliance can therefore be of help to obtain regulatory clearance.
The CDG’s are supported by reference software and by a test and certification program leaning on comprehensive test tools that validate genuine interoperability of products claiming compliance.
In summary the CDG’s help to achieve
- Lower product development cost for products applied in PCH solutions
- Shorter time-to-market (TTM) for PCH solutions
- Lower NRE for PCH solutions
- Reduced regulatory efforts and risks for PCH solutions
- Faster and easier business partnering in the PCH domain, with lower legal uncertainty
The CDG’s and the supportive assets are managed by the PCHAlliance, a part of HIMSS. There is no other such set of specifications available for the domain of personal connected health. And, in the future, the CDG’s will continue to expand adding in many new health, medical and wellness uses, new features, improved security, privacy and reliability for PCH.
With all these benefits, why is Continua not yet widely used?
There is substantial interest for Continua at the demand side of the market: the government of Denmark already in 2012 embraced the Continua Guidelines as the basis for its telehealth services; the government of Norway did the same for their telecare services in 2014. In 2017, the government of Catalonia mandated Continua compliance in a EUR 50m procurement of glucose meters. . To help support the acceleration of Continua adoption:
- PCHAlliance is supporting the movement of experimentation to scaled deployment by:
o Finding best practices for novel ways toward adjusting workflows and habits.
o Supporting policies that encourage financial incentives.
o Working with regulators to build strong regulations and risk containment.
- Educating vendors perceive on the adoption of open standards.
- Leading in the orchestration of HIT markets to create demand, enabling health authorities in any country the choice of interoperability through the very best of HIT practices (e.g. USA Meaningful Use, EU eHealth Network).
- Shortening the time-to-market for the adoption of open standards while fostering investment between buyers and vendors to match that of faster moving markets.
Why will vendors gain if the PCH solutions market adopts open standards?
Buyers need affordable PCH solutions that help them provide better care at lower cost. If vendors monopolize data assets, development resources are tied up in data conversions and communication, innovation will be slow, and meaningful applications will stay scarce and expensive. Thus, the market as a whole will not grow and vendors and buyers suffer. Data liberation and meaningful tools are required to turn PCH into a prosperous, sustained market reality. The scalability of this model will bring benefit to all players.
Unlike consumers, institutional buyers will not accept getting locked into a series of silo solutions by vendors who hesitate to open up their data. Neither will payers accept excessively high margins flowing from resulting dominant market positions. We already see push back against data hoarding and overly strong control points in the US, in HIT domains where oligopolies have developed over time. Thus, the strategy of competing through monopolizing health data has a weak, short sighted basis which is quite risky, for the majority of vendors.
Only very few players, if any, will be able to obtain and sustain leadership and commercial success by keeping health data for themselves. Therefore, vendors should foremost focus on what their customers need: data liberation and truly meaningful tools to deliver good care. Open standards need not be seen as a threat to a healthy competitive position but an enabler of market development in PCH. Continua is therefore the right way to go.
To become Continua Compliant, please visit: http://www.pchalliance.org/continua-certified-continua-compliant-process
 The one-time cost to research, develop, design and test a new product. When budgeting for a new product, NRE must be considered to analyze if a new product will be profitable.