Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Eucomed Issues Position Paper on eHealth

European medical technology industry trade group Eucomed has published a position paper on eHealth issues as the European Ministerial eHealth Conference gets underway in Budapest.

The association contends that seven high-level criteria must be met in terms of eHealth policies, programs and laws in order to improve uptake of such technologies across the EU.

First, eHealth policies should prioritize the needs of patient, providers and health care systems.

Second, frameworks developed for interoperability should support standardization and harmonization of national and local eHealth systems.

Third, value-based funding and reimbursement schemes should be implemented for eHealth technologies and services.

Fourth, legal certainty of eHealth products and services must be ensured across the EU.

Fifth, a centralized eHealth advocacy program should be established to keep focus on the value proposition eHealth products and services offer to EU health care systems.

Sixth, uptake of eHealth technologies should be done in a way that ensures effectiveness and efficiency.

Seventh, funding allocations to health care systems should give more priority to eHeath technologies and projects.

Eucomed’s paper further reiterated industry arguments that eHealth stands to improve quality of health care in Europe, provide greater efficiencies in health care delivery and data management, and more effectively promote best practices and knowledge sharing across EU member states.