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 healt 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 wihtin 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 very unique opportunity to change the way healthcare is provided today; to be more patient centric, less hospital centric and a much greater focus on prevention and management oriented approach through the appropriate use of technology.
The potential is widely recognized to enable greater health outcomes at lower cost. However, this will require that health providers have the adequate tools for acting on a rich and reliable set of relevant health data at their disposal guiding them towards better decisions with the diagnosis, treatment and support within efficient work flows.
As many hurdles exist, this transition is not currently obvious. The CDG aims to resolve one specific hurdle, namely the difficulties experienced by implementers to technically integrate solutions that support PCH devices and services. More specifically, it fosters integration to enable medical- grade health data to flow from a multitude of vital signs device sensor data used by individuals to health services and all the way into a hospitals EHR’s in a safe and secure manner.
Why should market actors even bother?
Market actors of different kinds face the obstacle of non-interoperability between elements needed to compose integral PCH solutions:
- Vital signs sensor vendors see their market segmented along different modes of communication with health service providers and the systems they use in their operation. They lose the non-recurring engineering (NRE) and throughput time to adjust their offerings time and again, or must accept that some market segments stay out of reach.
- PCH system providers face a similar issue: to connect to a multitude of sensors, they have to spend development resources to integrate them in many different ways.
- 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. If instead they buy a vertically integrated solution from a single vendor, they get 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 narrow scope of care and use only limited technology, e.g. using blood sugar level as the sole input to manage only diabetes. This mismatches the reality of many 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 it’s composing elements, but in case the integration is ad hoc rather than well planned for, 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 a waste, as the value of PCH solutions is not in the integration but in the innovative care support functions that can be unleashed by a free flow of health data.
How could Continua help resolve this?
The CDG’s specify an end-to-end ICT framework for PCH solutions based on recognized open standards, to create a secure and interoperable health data exchange in personal connected health. They enable the secure flow of medical-grade data among sensors, gateways, and end services by providing clear guidance how to shape a set of clearly defined interfaces between these elements by further clarification of the standards and by picking appropriate options for their application, adding necessary features that are missing in the underlying standard or specification.[KM1]
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 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.
If Continua has these benefits, why is it not yet widely used?
There is actually substantial interest for Continua at the demand side of the market . However, there are several hurdles that explain why Continua take-up is slow so far.
- As technical hurdles are not the only factor keeping PCH from breaking through massively, the market is still experimenting and not growing very fast.
o Finding best practices for novel ways, and adjusting the work flows and habits, takes time.
o Adjustment is slowed down by existing financial incentives.
o Adjustment is slowed down by strong regulations and risk containment.
- Every new standard passes a period of stallment in which buyers and vendors wait for the other side to invest first. With slow market uptake of innovations, this period is longer than in fast moving markets.
- There is little demand orchestration in HIT markets. While in many countries health authorities aim to converge demand towards a limited set of interoperability choices (e.g. USA Meaningful Use, EU eHealth Network) these attempts have only little enforcement powers.
- Many vendors perceive that by adopting open standards, they give away competitive advantage.
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[KM2] 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 will not grow and vendors and buyers suffer. Data liberation and meaningful tools are required to turn PCH into a prosperous market reality. Scale 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 basis and is quite risky, for the majority of vendors.
Only very few players, if any, will be able to obtain and sustain leadership 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. Continua is therefore the right way to go.
 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.