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The Regulation of Privacy and Data Protection in the Use of Electronic Health Information

The Regulation of Privacy and Data Protection in the Use of Electronic Health Information

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Published by: rodrigur8036 on Dec 03, 2012
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The European Union Directive 95/46/EC of the
European Parliament and of the Council of 24 October 1995 [33]
represents the first comprehensive effort to implement an international
harmonization privacy framework. As previously examined data
protection rules in the EU not only regulate processing personal data in
the EU Member States but also comprise provisions on the transfer of
data to third countries (Articles 25 and 26 of the Directive 95/46/EC).
The basic criterion is that Member States should permit transfer of
personal data only when the third countries concerned ensure an
appropriate level of protection. If an appropriate protection level cannot
be ensured, and on the assumption that none of the exceptions
envisaged would apply, Member States would prevent those transfers.

Although the EU countries and the U.S. share similar concerns
about the impact of electronic networks on the information privacy, the
EU has addressed these concerns in very different ways from the U.S.
When the Transatlantic Business Dialogue (TABD) met in November
1997, both European and American participants recognized the threats
to global commerce posed by privacy regimes that require conformity to
a certain approach. It supported mutual recognition by governments of
industry-led, market-driven privacy protection principles to ensure
consumer trust in electronic commerce. It also suggested that national
privacy protection allow for differences in privacy protection, based on
national political systems and local cultures. The TABD urged the
governments of both the U.S. and the EU to work together with industry
to understand how market-driven, self-regulatory solutions provide
protection of, and ensure the continuation of, transborder personal data
flows [351].

Following the lead of the EU, most countries in Latin America,
New Zealand, Canada, and the Asia-Pacific region have chosen the
legislative path, as opposed to self-regulation, the model sponsored by
the U.S. and Japan. The global trend has been toward the adoption of
legislation type models – Australia, which initially preferred a self-

Global Harmonization Initiatives


regulating approach, has backed away from self-regulation and is now
adopting the legislative model [352].

Regardless of the regulatory model that is implemented, the
goal is to ensure the development, agreement, and application of a fair
and predictable set of rules across countries and regions, and to reduce
the complications of jurisdiction and applicable law.

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