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Changes to CLIA and HIPAA Provide Greater Patient Access to Laboratory Test Reports

On February 3, 2014, the U.S. Department of Health and Human Services (HHS) released a long-awaited final rule that amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy regulations to permit patients and their personal representatives to access laboratory test reports. By requiring expanded access, HHS rejects what some have characterized as “paternalistic” arguments that such reports are complicated and should be provided only through treating physicians. HHS justifies the rule as necessary to empower patients to take an active role in managing their health and healthcare. As anyone who has tried to interpret a laboratory test report can attest, whether the stated objectives of the new rule will be achieved has yet to be seen.

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European Parliament’s Civil Liberties Committee Report calls for immediate suspension of Safe Harbor

A draft report by the European Parliament’s Civil Liberties Committee (the LIBE Committee) indicates that it is attempting to fundamentally alter the existing compliance mechanisms for transferring personal data from Europe. The recently leaked draft is dated December 23, 2013 and expresses the LIBE Committee’s response to the U.S. NSA surveillance programs, surveillance in various EU Member States and the impact on EU citizen’s fundamental rights and on transatlantic cooperation (the Report).

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Data protection challenges in the new era of Big Data

Data Protection Law & Policy

“Data is the new oil” – This statement by Neelie Kroes in 2011 has since been on everyone’s mind and with the constant development of new technologies, the importance of data has grown dramatically over the past few years and in recognition of this it seems that we have now entered into a new era: the era of Big Data. William Long and Geraldine Scali, Partner and Associate respectively at Sidley Austin LLP explore the potential data protection issues that may arise.

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Heads Up for Privacy, Data Protection and Cybersecurity in 2014

The new year will ring in significant privacy, data protection and cybersecurity changes in the U.S., Europe, Asia and elsewhere around the world. Below are some key developments and possible concrete action items for General Counsels, Chief Privacy Officers and Chief Information Officers:

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European Commission makes recommendations to strengthen Safe Harbor

The European Commission has released a comprehensive package of communications, reports and papers that set out actions which the Commission believes can restore trust in transatlantic data flows between the European Union and the United States following recent concerns over access to data by intelligence agencies.

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European Parliament votes on new EU Data Protection Regulation

The European Parliament’s Civil Liberties Committee (the “LIBE Committee”) has after several delays finally voted on the European Commission’s proposed EU Data Protection Regulation and adopted all amendments. The LIBE Committee also approved a mandate to start negotiations with the Council of Ministers (which represents EU Member States) and the Commission – the so called trilogue process. The Regulation was published by the European Commission in January 2012 and has been described as the most lobbied piece of European legislation in history receiving over 4,000 amendments in opinions from other Committees in the European Parliament as well as from numerous industries.

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The UK Data Protection Authority issues a Code of practice on anonymization

In November 2012, the UK Information Commissioner’s Office (ICO) published a Code of Practice on managing data protection risks related to anonymization. This Code provides a framework for organisations considering using anonymization and explains what it expects from organisations using such processors.

One of the benefits of anonymization is that the onerous data protection obligations under EU data protection laws, including the UK’s Data Protection Act 1998, will not apply to data rendered anonymous such that individuals are no longer identifiable.

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Business Concern over Amendments to Proposed EU Data Protection Regulation

The European Parliament’s Civil Liberties Committee has published its draft report on the proposed EU Data Protection Regulation that is causing concern for many corporations. http://www.europarl.europa.eu/meetdocs/2009_2014/documents/libe/pr/922/922387/922387en.pdf.

The report sets out amendments to the draft EU data protection regulation published by the European Commission last January (the “Regulation”)
http://ec.europa.eu/justice/data-protection/document/review2012/com_2012_11_en.pdf.

Despite being one of the most lobbied pieces of European legislation, many will be disappointed that as amended the draft Regulation still imposes very significant burdens on businesses that are in the EU, or which are outside the EU but offer goods or services to EU customers, with fines of up to 2% of annual worldwide turnover.

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<a target=‘_blank’ href="https://www.sidley.com/en/people/a/akowuah-kwaku-a">Kwaku A. Akowuah</a>

Kwaku A. Akowuah

Washington, D.C.
<a target=‘_blank’ href="https://www.sidley.com/en/people/a/armbrust-sheila-a-g">Sheila A.G. Armbrust</a>

Sheila A.G. Armbrust

San Francisco
<a target=‘_blank’ href="https://www.sidley.com/en/people/b/blythe-francesca">Francesca Blythe</a>

Francesca Blythe

London
<a target=‘_blank’ href="https://www.sidley.com/en/people/b/brown-colleen-theresa">Colleen Theresa Brown</a>

Colleen Theresa Brown

Washington, D.C.

<a target=‘_blank’ href="https://www.sidley.com/en/people/c/casanova-john-m">John M. Casanova</a>

John M. Casanova

London
<a target=‘_blank’ href="https://www.sidley.com/en/people/c/cunningham-thomas-d">Thomas D. Cunningham</a>

Thomas D. Cunningham

Chicago
<a target=‘_blank’ href="https://www.sidley.com/en/people/i/ishiara-tomoki">Tomoki Ishiara</a>

Tomoki Ishiara

Tokyo
<a target=‘_blank’ href="https://www.sidley.com/en/people/l/lally-amy-p">Amy P. Lally</a>

Amy P. Lally

Century City
<a target=‘_blank’ href="https://www.sidley.com/en/people/l/lashway-david-c">David C. Lashway</a>

David C. Lashway

Washington, D.C.
<a target=‘_blank’ href="https://www.sidley.com/en/people/l/lieu-linh">Linh Lieu</a>

Linh Lieu

Hong Kong
<a target=‘_blank’ href="https://www.sidley.com/en/people/l/long-william-rm">William RM Long</a>

William RM Long

London
<a target=‘_blank’ href="https://www.sidley.com/en/people/l/loughnane-joan-m">Joan M. Loughnane</a>

Joan M. Loughnane

New York
<a target=‘_blank’ href="https://www.sidley.com/en/people/m/malhotra-geeta">Geeta Malhotra</a>

Geeta Malhotra

Chicago
<a target=‘_blank’ href="https://www.sidley.com/en/people/r/raul-alan-charles">Alan Charles Raul</a>

Alan Charles Raul

Washington, D.C., New York
<a target=‘_blank’ href="https://www.sidley.com/en/people/r/royall-m-sean">Sean Royall</a>

Sean Royall

Dallas, Washington, D.C.
<a target=‘_blank’ href="https://www.sidley.com/en/people/s/seale-jennifer-b">Jennifer B. Seale</a>

Jennifer B. Seale

Washington, D.C.
<a target=‘_blank’ href="https://www.sidley.com/en/people/t/tham-yuet-ming">Yuet Ming Tham</a>

Yuet Ming Tham

Singapore, Hong Kong
<a target=‘_blank’ href="https://www.sidley.com/en/people/v/van-de-weert-jr-john-k">John K. Van De Weert</a>

John K. Van De Weert

Washington, D.C.
<a target=‘_blank’ href="https://www.sidley.com/en/people/w/wilan-jonathan-m">Jonathan M. Wilan</a>

Jonathan M. Wilan

Washington, D.C.
<a target=‘_blank’ href="https://www.sidley.com/en/people/w/woods-jr-john-w">John W. Woods Jr.</a>

John W. Woods Jr.

Washington, D.C.

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