Informed Consent

News & Analysis as of

Optical Express appeal highlights the need for caution over third-party marketing lists

In a decision of 31 August 2015, the First-Tier Tribunal provided important clarification on the use of third-party mailing lists. Optical Express v Information Commissioner (EA/2014/0014) is significant for organisations...more

The European Commission Issues Guidance on Alternative Cross-Border Data Transfer Tools

On November 6, 2015, one month after the European Court of Justice decision that invalidated the Safe Harbor framework, the European Commission (the “Commission”) issued a Communication setting forth its position on...more

Round-up of Safe Harbor guidance issued by EU Data Protection Authorities

October has been a busy month for Data Protection Authorities in the EU. Following the Court of Justice of the European Union’s judgment in Maximillian Schrems v Data Protection Commissioner (C-362-14) on 6 October,...more

Are Chiropractors Subject to Medical Malpractice Law in Illinois?

Many patients in Chicago seek chiropractic treatment each year. For some patients, however, Chiropractic treatment leads to injury, or even death. These cases leave many patients and their families wondering if they can...more

Safe Harbor Update: Safe Harbor Sequel Coming Soon?

As we wrote on October 6, 2015, the Court of Justice of the European Union (CJEU) announced its invalidation of the U.S.-EU Safe Harbor program as a legally valid pathway for transferring personal data of European Union (EU)...more

No Safe Harbour? Immediate Implications for Employers

A landmark decision of the European Court of Justice (ECJ) has held that companies may no longer rely on “Safe Harbour” to justify transferring personal data from the European Union to the US, because the US Government has a...more

A German DPA Questions the Validity of the Use of Consent and Model Contractual Clauses to Transfer Personal Data to the U.S.

Just one week after the milestone decision rendered by the CJEU to invalidate the Safe Harbor program established 15 years ago between the U.S. and the EU to facilitate the transfer of personal data from the EU to the U.S., a...more

The Safe Harbor Ruling – FAQs and What Your Business Should Do Now

Overview questions - 1. I’m Safe Harbor certified and have seen news articles reporting that “Safe Harbor is invalid”. What does that mean? On 6 October, the European Court of Justice delivered a judgment which...more

Any Port in a Storm? EU-US Data Transfers After Schrems and Safe Harbor

Last week, the Court of Justice of the European Union (CJEU) gave an important ruling which any business transferring personal data between the EU and the United States should know about — in particular those that make use of...more

Non-compliance with new EU data privacy rules can be costly

On October 6, Europe’s highest court, the Court of Justice of the European Union, struck down the “Safe Harbor Framework,” which existed between the United States and the EU for 15 years. This has an impact on companies...more

International Life Sciences Data Transfers After Schrems

With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more

Effects of Schrems Ruling on International Internal Investigations

In a recent landmark decision, Maximillian Schrems v. Data Protection Commissioner, Europe’s highest court struck down a US-EU agreement that allowed companies to move personal electronic data between the European Union and...more

Court Invalidates US-EU Data Transfer Safe Harbor Program

The European Union’s highest court has, effective immediately, invalidated the US-EU Safe Harbor program relied upon by many companies as the basis for lawfully transferring and processing personal information from the EU to...more

US-EU Safe Harbor Invalidated: What Now?

On October 6, 2015, the European Court of Justice (CJEU) invalidated the US-EU Safe Harbor framework, effective immediately. This momentous decision jeopardizes the continued flow of data from Europe to the US. As the Safe...more

Keep Calm and Data Transfer On (… mostly … for now) - M&E Cybersecurity & Data Privacy Alert

Most of you already have Twitter feeds, Facebook pages, and—the aged among you—in-boxes overflowing with news about yesterday’s decision from the European Court of Justice (“ECJ”). Some of you read each message, anxiously...more

Safe Harbor Invalidated – What’s Next on the Chopping Block?

As I reported earlier today, the Court of Justice of the EU (ECJ) has declared Safe Harbor invalid. The full decision is now available online in English (other languages also available at by searching on...more

EU Top Court’s Safe Harbor Decision Invalidates Safe Harbor and Sends Facebook Case Back to Irish Data Protection Authority

The initial reports of the ECJ’s decision in the Schrems Safe Harbor case (C-362/14) indicate that the Court of Justice of the EU has declared Safe Harbor invalid and sent the case back to the Irish Data Protection Authority...more

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

ECJ Advocate General’s Safe Harbor Opinion Points Towards Imminent End of Safe Harbor As We Know It

Does your company rely on Safe Harbor to transfer personal data from Europe to the US? If so, it’s time to think about alternatives to Safe Harbor – and fast....more

HHS Releases Notice of Proposed Rulemaking Updating Rules for Human Subjects Research

On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of...more

HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more

Anything in the New Clinical Trial Rules of Interest to Product Liability? Not Really.

An inter-agency taskforce is proposing a comprehensive overhaul of “Federal Policy for the Protection of Human Subjects” in today’s issue of the Federal Register (comments close on 12/7/2015). See 80 Fed. Reg. 53933 (Sept....more

Drastic Changes Proposed for Clinical Research Rules

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more

HHS Proposes Major Overhaul of the Common Rule

On September 8, 2015, the Department of Health and Human Services proposed significant revisions to the Federal Policy for the Protection of Human Subjects (“Common Rule”), the set of federal regulations governing the conduct...more

Blog: “Common Rule” Overhaul Proposed – Intended to Modernize Human Research Subject Protections

On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”. The Common...more

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