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Images can now cross borders, but what about the legislation?

Images can now cross borders, but what about the legislation?

The sharing of patient data between healthcare organizations and IT systems is changing from a “point to point” model to a “many to many” one. Patient information now needs to be shared across workspaces and communities and medical experts working in different countries need to be reached, as well.

New technical standards and profiles are emerging to support these trends globally. Meanwhile, the European Commission is supporting moves that will facilitate cross-border interoperability of e-health systems and remove potential legal hurdles. National patient data exchange platforms are being built all over Europe to support data sharing across organizations in a trusted and secure way. A project has also been set up to connect these national platforms to each other so that patient data can be viewed across national boundaries (www.epsos.eu/)

Commercially available solutions allow global, shared work lists to be built across different PACS and RIS, not only for viewing and sharing of data but for true shared workflow. This enables efficient workforce utilization—within and even between different countries—for remote reporting, second opinions, and clinical conferencing.

BALANCING WORKLOADS

Global work lists remove the need to manually manage who reads what when and where. Studies are locked when they are being read, and then unlocked and updated once reading is complete. Radiologists serving multiple healthcare facilities can consequently read and report “virtually” across large geographical areas. This is an excellent way to balance workloads locally or regionally between sites with different RIS/PACS. In Ireland, for example, a nationwide scheme is being implemented that will allow any examination, together with relevant prior examinations and/or supporting patient information, to be viewed and reported anywhere in the country, regardless of where the images were acquired.

Dynamic sharing rules can be set up, too. If a pediatric radiologist at one hospital calls in sick, for example, a decision can be made to share all pediatric examinations with the pediatric clinic of a larger hospital or an external teleradiology company, just for that one day.

So called e-marketplaces, such as the EU-funded R-Bay project (www.r-bay.org/), are being investigated in both Europe and the U.S., allowing end users and teleradiology providers from different countries to interact through a central platform. This will enable stakeholders to compare prices, availabilities, response times, quality, subspecialty expertise, etc. In return, the e-marketplace will receive a fee for transactions made through its platform. This is a controlled way to practice teleradiology with transparent quality assurance, centralized certification databases, and uniform data privacy and security policies.

LEGAL CLARITY

The biggest challenges when images cross national borders relate to interoperability and legal clarity. Technical interoperability will be solved to a certain extent through standards, IHE profiles, and certification procedures. There is still a lot to do, however, in terms of semantic and legal issues. Legislation relating to teleradiology and e-health, including the remote archiving of medical data, informed consent requirements, and liability issues, can vary considerably. In some countries it is almost forbidden to practice teleradiology.

The variety of languages spoken within the EU is also a problem. Radiologists should be able to report in their own native language, but the referring clinician and the patient in another country must understand the report as well. One option may be to use structured multilingual reporting templates, though these are not yet available for all anatomical regions.

A new EU directive on cross-border healthcare is currently under review. This suggests that healthcare should be provided according to the legislation of the member state that is providing the service, regardless of which country the patient is insured in. Standards and guidelines on quality will also be defined by the member state providing the treatment. If the radiologist is working outside the EU—but works for an EU-registered company, the same rules will apply.

Further clarification of the legal situation is needed. The market for e-health and teleradiology is, as ever, evolving more rapidly than any directives and laws.

Disclosures

 
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