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E-health and mobile medical devices: promises and challenges / by Eugene Clark, September 11, 2014 Adjust font size:

Legal and other risks

However, there are legal and other risks that need to be considered.

• Uncertainties involving licensing laws; for example, to what extent must a particular e-health care delivery application be performed by licensed professionals and how to handle care across jurisdictions? If a dispute occurs, what law is to be applied? This is especially problematic when different countries are involved.

• Uncertainties as to whether a particular new device is a "medical" device requiring compliance with strict regulation or a mere "consumer device" that provides helpful bio-feedback to a consumer.

• Malpractice liability uncertainties, for example in the use of robotics.

• Privacy of patient records, especially in relation to trans-border transmission of data, especially in this era of cloud computing.

• Insurance issues, for example regarding interpretation of standard terms and whether and to what extent these terms apply in e-health care settings.

• Intellectual property issues, including legal protection of a new form of e-health care delivery and telecommunications laws governing the overall infrastructure over which e-health care delivery takes place.

Legal issues must also be viewed within the larger context of overall risk identification, assessment and management of the emerging areas of e-health care delivery. The challenge is to develop a management and legal infrastructure which encourages innovation, promotes transparency and encourages continued improvement and sharing of emerging best practices.

Another issue is that many e-health initiatives are likely to be developed through public-private partnerships, so policy and legislative frameworks and operational guidelines will have to be developed.

These new technologies will likely disrupt existing power relationships in the health field and effective change management mechanisms will have to be in place if society is to gain the full benefit of new technological advancements in e-health.

International cooperation

It is also important for e-health developers to cooperate internationally. An example is the International Medical Device Regulators Forum – a voluntary group of national medical device regulators.

This is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.

In 2014, the Forum established the Standalone Medical Device Software Working Group to develop a uniform approach to the regulation of standalone medical device software, including mobile medical apps.

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