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One Step Forward, Two Steps Back: FDA’s Final Guidance on Clinical Decision Software Raises More Questions Than Answers

Recently, the U.S. Food and Drug Administration (FDA) published a suite of guidance documents relating to software, automation, and artificial intelligence. One guidance document in particular, addressing clinical decision support (CDS) software, may signal a tightening in FDA’s oversight on software tools with artificial intelligence and machine learning (AI/ML) that could introduce confusion and frustrate innovation in this important, fast-developing area. On October 18, 2022, FDA held a webinar to provide additional clarifications on this final guidance.

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White House Publishes In-Depth Guidance on the Use of Automated Systems and Recognizes Privacy as Foundational Principle of Framework

On October 4, 2022, the White House Office of Science and Technology Policy published The Blueprint for an AI Bill of Rights: Making Automated Systems Work for the American People (the “AI Blueprint”). The AI Blueprint outlines non-binding guidelines for the development and deployment of automated systems and is the culmination of a year-long process of public engagement and deliberation.

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U.S. Treasury Department Seeks Public Comment On Potential Federal Cyber Insurance Program

The U.S. Treasury Department is seeking public comment on the need and scope for a potential federal insurance response to catastrophic cyber incidents, akin to the one put in place for terrorism insurance after the attacks of September 11, 2001.

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U.S.-EU Data Transfer Framework Signals Strengthened Collaboration

*This article first appeared on Law360 on October 14, 2022

A series of coordinated announcements on Oct. 7 lifted the veil on a new trans-Atlantic data transfer mechanism.

This announcement has been hotly anticipated since a joint declaration from the U.S. and European Union governments on March 25, that there was an agreement in principle for a new EU-U.S. Data Privacy Framework.

The key document in the framework process is Executive Order No. 14086 on enhancing safeguards for U.S. signals intelligence activities, accompanied by a detailed fact sheet on the executive order.

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Uber Data Breach Results in Corporate Cooperation and Executive Conviction

On October 5, 2022, a federal jury in the Northern District of California convicted former Uber Chief Security Officer Joseph Sullivan of obstructing a federal proceeding and misprision of a felony for his role in deceiving management and the federal government to cover up a 2016 data breach that exposed personally identifiable information (“PII”) of approximately 57 million users, including approximately 600,000 drivers’ license numbers, of the ride-hailing service. Sullivan, a former federal prosecutor, appears to be the first corporate executive criminally prosecuted—let alone convicted—for his response to a data security incident perpetrated by criminals. Sullivan faces a maximum of five years in prison for the obstruction charge, and a maximum three years in prison for the misprision charge.

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The FTC’s COPPA Conundrum: Ambiguities in the Rule and a Death of Authoritative Guidance Leave the Agency Vulnerable to Legal Challenges

This article was originally published by the ABA’s ANTITRUST magazine in its Summer 2022 issue.

The Children’s Online Privacy Protection Act (COPPA) and the Federal Trade Commission’s COPPA-enforcing rule have increasing relevance for all businesses that interact directly with consumers online—including companies that do not regard themselves as marketing directly to children. Both the FTC and state Attorneys General are active in enforcing COPPA, and companies can often be caught off guard by government inquiries scrutinizing their compliance. (more…)

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Sean Royall

Dallas, Washington, D.C.

sroyall@sidley.com

ICO Publishes Draft New Guidance on PETs

On 7 September 2022, the Information Commissioner’s Office (“ICO”) published draft guidance (“Guidance”) on privacy-enhancing technologies (“PETs”). It is hoped that the Guidance will help organizations have the confidence to utilize PETs to develop innovative applications without compromising on privacy concerns, or trust. The Guidance is divided into two sections: (i) how can PETs help with data protection compliance; and (ii) what are PETs. We consider the key learning points from the Guidance below.  (more…)

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Unpacking New Digital Data Laws Across Europe: Addressing the Digital Markets Act

Join Sidley and OneTrust DataGuidance for a webinar focusing on the new EU legislation regulating big online platforms, the Digital Markets Act (DMA). As the DMA will soon be coming into force, many complex questions as to its implementation are bound to arise.

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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/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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