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Susan Foster is a Member in the Corporate & Securities Section, practicing in the firm’s London office. She works with clients primarily on data protection, licensing, collaborations, and commercial matters in the fields of clean tech, high tech, mobile media, and life sciences. She has represented a broad range of clients from start-up companies to international industry leaders and has significant experience with cross-border transactions. She is qualified in England and Wales as well as California, and has experience practicing law in both the United States and the United Kingdom.

In case you had not heard, the European Union is replacing its current privacy laws with a new, comprehensive General Data Protection Regulation (GDPR), which takes effect May 25, 2018. The essential principles of the EU’s privacy laws are unchanged, but the new Regulation imposes many new obligations on many more entities – all backed up by fines modeled on European antitrust laws. US Life Sciences companies are likely to find that the GDPR applies to their use of personal information that originated in the EU. This post suggests some pragmatic steps companies can take to assess and begin to meet their GDPR obligations.   We’ll be presenting the next webinar in our GDPR series particularly targeted to life sciences and biotech companies and that will be coming up in March.  Watch this space for more information and registration.

Step 1 – Confirm that the GDPR Applies Continue Reading Practical GDPR Steps for US-Headquartered Life Sciences Companies

The European Commission has launched a new data protection website aimed at educating the public and helping businesses and other organizations comply with their new obligations under the General Data Protection Regulation.  The Commission’s website contains some infographics to help readers get to grips with the key points of the GDPR.  It also contains Q&A and examples that may be helpful in assessing when the GDPR’s various obligations are triggered in different situations.

While the infographics approach to explaining companies’ GDPR obligations have the virtue of simplicity, the Commission’s explanation of what smaller companies must do is far from exhaustive and might mislead readers into thinking they are in compliance when they are not.  For example, the explanation of the record keeping requirements mentions three criteria that trigger the requirements for companies with under 250 employees (SMEs), but omits a critical “or” between the infographic’s second (risky processing of any personal data) and third criteria (processing of sensitive data or criminal records).  Small companies could easily be misled into thinking that only processing that meets all three criteria requires record-keeping.

Larger companies that are subject to the GDPR will likely find the Commission’s SME-focused infographics useful, but should approach with a bit of caution.  Their data processing activities will require record-keeping and, since larger companies are typically more complex, it may require deeper analysis to get to grips with their GDPR obligations.

That said, companies looking for a digestible, visually engaging explanation of their responsibilities under the GDPR will find this a useful addition to their GDPR preparation toolkit.

One of the most striking changes to EU privacy law under the EU’s General Data Protection Regulation (which goes into effect May 25, 2018) is the very strict approach to user consent.    For many years, companies operating in the EU (as elsewhere) have relied heavily on user consent to achieve compliance with the relevant data protection and direct marketing laws.   When the GDPR was first published, it became clear that the EU intended to crack down on the use of consent in many common situations where the EU felt that individuals were not being treated fairly.

Draft guidance published on Dec. 18 by a key advisory body representing the EU’s national data protection authorities , the Article 29 Working Party (WP29),  has confirmed that regulators will approach consent strictly.  The guidance is worth reading in full.  Some highlights:

  • Consent cannot be bundled.  Instead, consents must be granular.  You will need a separate consent for each purpose for which data will be processed.  WP29 notes that this could easily lead to “click fatigue” (implicitly casting doubt on the validity of the consent) when individuals are routinely presented with a long set of check boxes, but WP29 says that this is a problem for data controllers to solve.
  • Consent to “unnecessary” uses of personal data cannot be used as a quid pro quo for access to a service.  This confirms our previous suggestion that the GDPR invalidates the prevalent business model of providing free services (such as a free app) in exchange for access to personal data that is used for behavioral advertising or other marketing purposes.
  • The “explicit” consent needed for processing sensitive personal data requires something even stronger than the already-stringent standard for “normal” consent under the GDPR.  The guidance suggests several mechanisms that primarily involve an extra confirmation step by the user, such as clicking on an opt-in box and then responding affirmatively to a text or e-mail to confirm the consent.  It’s not clear that users will welcome the extra steps and delay, but WP29 maintains that there needs to be something “more” to reach the level of “explicit” consent.
  • Data controllers must identify their legal bases for processing in advance and cannot “swap” bases if the initial basis for processing proves defective.  In other words, controllers cannot have a “backup” basis for a given processing operation, even when a given processing activities could be done on one of a number of bases, such as necessity for contract performance, legitimate interest, or consent.

The draft guidance is open for public comment until January 23, 2018.

Since last September, the Mintz Levin Privacy Webinar Series has focused on the upcoming EU General Data Protection Regulation (GDPR) to help businesses understand the reach and scope of the GDPR and prepare for the potentially game-changing privacy regulation. The GDPR will affect how US businesses handle and process personal data originating in the EU and may require changes to business process.

Getting Your Contracts Ready for GDPR (11/16/2017)

This webinar, the eighth in our EU General Data Protection Regulation Series, reviews the GDPR’s express contract requirements and discusses additional matters that you may want to address in your contracts.

Handling Human Resources Data Under Privacy Shield and the GDPR (10/5/2017)

This webinar, the seventh in our EU General Data Protection Regulation Series, reviews current options for transferring personal data, including under Privacy Shield, and previews the new landscape under GDPR.

Access, Correction and Erasure: How to Minimize the Burden (2/16/2017)

This webinar, the sixth in our EU General Data Protection Regulation Series, considers companies’ obligations to give individuals access to their data and to correct or erase it.  We explore the new data portability requirements. The webinar concludes with some suggestions on how to make these requirements less burdensome.

Transferring Data from the EU (1/12/2017)

This webinar, the fifth in our EU General Data Protection Regulation Series, explores the ways in which the Regulation creates new avenues for data transfers, and narrows others. In particular, we consider sector-specific Commission decisions, privacy seals/certifications, the exception for non-repetitive, limited transfers, and the outlook for BCRs and Model Clauses.

Data Protection Officers: Do You Need One? (12/15/2016)

This webinar, the fourth in our EU General Data Protection Regulation Series, examines the criteria that dictate whether or not your organization needs to appoint a Data Protection Officer. We discuss the role of the DPO, the significance of the “independence” requirement, and the qualifications required to hold the position.

Good-bye to the Cure-all: The New Rules on Consent (11/10/2016)

This webinar, the third in our EU General Data Protection Regulation Series, reviews the new restrictions on relying on user consent to data processing and data transfers. In addition to the general “imbalance of power” problem, we consider the implications of the Directive on unfair terms in consumer contracts and changes that may need to be made to terms of use and privacy policies when dealing with consumers.

Accountability, Data Security, Data Impact Assessments and Breach Notification Requirements (10/13/2016)

This webinar, the second in our EU General Data Protection Regulation Series, focuses on the data security and accountability requirements of the Regulation, including reviews and documentation of internal policies and procedures and data impact assessments. We also explore the breach notification requirements and actions that companies can take in advance to mitigate the need for breach notification.

One-Stop Shopping Mall? The New Regulatory Structure (9/14/2016)

This webinar, the first in our EU General Data Protection Regulation Series, explains the powers and role of the new European Data Protection Board, how a “lead supervisory authority” will be designated for each controller, and how the lead supervisory authority will interact with other interested supervisory authorities. We also look at the complaint process from the point of view of the individual who is claiming a violation, and explore the likely role that will be played by public interest organizations bringing group complaints.

Spoiler Alert: Behavioral advertising companies will find some bad news in the guidance.

The Article 29 Working Party (WP29) advisory group, which will soon become the more transparently-named (and very powerful) European Data Protection Board, is busy drafting and issuing guidance documents to help organizations understand how European data protection authorities will interpret various requirements of the General Data Protection Regulation (GDPR).  WP29 recently issued draft guidance relating to automated decision-making and profiling that will be critical for all organizations that conduct those activities. The draft guidance is open for comments until Nov. 28, 2017.  This post recaps some of the particularly interesting aspects of the draft guidance, which can be found in full here (scroll down to the items just above the “Adopted Guidelines” section).

But first, what counts as automated decision-making under the GDPR?  And what is “profiling”? Continue Reading Key GDPR Guidance on Behavioral Advertising, Profiling and Automated Decision-Making

As was generally expected from informal comments by EU representatives, Privacy Shield has survived its first annual review.  Commissioner Jourova stated: “Our first review shows that the Privacy Shield works well, but there is some room for improving its implementation.”  Specifically, the Commission highlighted the following in the press release today in which it announced its conclusions:

  • More proactive and regular monitoring of companies’ compliance with their Privacy Shield obligations by the U.S. Department of Commerce. The U.S. Department of Commerce should also conduct regular searches for companies making false claims about their participation in the Privacy Shield.
  • More awareness-raising for EU individuals about how to exercise their rights under the Privacy Shield, notably on how to lodge complaints.
  • Closer cooperation between privacy enforcers i.e. the U.S. Department of Commerce, the Federal Trade Commission, and the EU Data Protection Authorities (DPAs), notably to develop guidance for companies and enforcers.
  • Enshrining the protection for non-Americans offered by Presidential Policy Directive 28 (PPD-28), as part of the ongoing debate in the U.S. on the reauthorisation and reform of Section 702 of the Foreign Intelligence Surveillance Act (FISA).
  • To appoint as soon as possible a permanent Privacy Shield Ombudsperson, as well as ensuring the empty posts are filled on the Privacy and Civil Liberties Oversight Board (PCLOB).

It’s worth noting the recommendation regarding enshrining the protections for non-Americans under Presidential Policy Directive 28 in the reauthorization of Section 702 — while President Trump has not withdrawn PPD-28, it’s not a given that protection for foreigners will be built into FISA.

The full report is available here.

Executive summary:  The EU’s standard contractual clauses may be on the fast track to invalidation, putting a vast number of personal data transfers from the EEA at risk.  A case brought by Maximilian Schrems (whose first complaint resulted in the invalidation of Safe Harbor) has been referred to the EU’s highest court, via a 153-page Irish High Court decision that provides ample ammunition to those who would like to see the standard contractual clauses struck down.  Although aimed at Facebook, the consequences of the decision are virtually certain to affect all US companies that rely on the standard contractual clauses.

Many companies around the world rely on the EU’s standard contractual clauses (also known as the model clauses, and referred to in this article as the “SCCs”) as the legal basis for transferring personal data from the European Economic Area (EEA) to countries whose privacy laws have not been found adequate by the EU Commission.  The SCCs are private contracts, and while some EEA countries require that parties that enter into SCCs deposit a copy, other countries do not, so no one knows for sure how many companies rely on the SCCs.  But the answer is probably “an awful lot of companies.”  Given the data flows between the EEA and US, and the fact that, as of today, only around 2,500 companies rely on Privacy Shield as the legal basis for the data transfers, it’s safe to assume that for US companies, the standard contractual clauses are the primary mechanism for transferring personal data to the US.

The SCCs have been subject to a legal challenge by Maximillian Schrems (often called the Schrems II case) that has just reached a critical inflection point: The Irish High Court has just issued a decision referring to the Court of Justice of the EU (CJEU) the question of whether the SCCs are invalid.  The main thrust of the invalidity argument is the assertion that US national security laws do not offer adequate levels of protection for the rights of EU residents.  In particular, the argument runs, EU residents lack a meaningful remedy before US courts for uses of their personal data by US national security agencies that are inconsistent with those persons’ rights under EU law. Continue Reading Will the EU box itself in?  Fate of Standard Contractual Clauses (aka the Model Clauses) for personal data transfers is now in the hands of the EU’s highest court

Many companies have started the potentially lengthy process of auditing their service provider contracts to make sure that they comply with the requirements of the General Data Protection Regulation, which comes into force on May 25, 2018.

Fortunately for those companies that are trying to kick-start their contract audit process, the UK Information Commissioner’s Office (ICO) is forging ahead with its promised series of guidance documents to help companies get ready for the GDPR. The latest addition is a draft guidance note on the GDPR’s requirements for contracts between data controllers (the folks who make decisions about what personal data will be processed, and for what purposes) and data processors (the folks who carry out processing activities on behalf of a data controller).

The requirement that there be a contract between data controllers and their data processors is not itself new.  Current EU data protection law requires data controllers to have contracts with data processors governing the security of the personal data held by the processor and requiring processor to process the personal data solely in accordance with the instructions of the controller.

But the contract requirements under the GDPR are much more expansive. Continue Reading Have you started auditing your contracts with your service providers that handle EU personal data?  UK Information Commissioner’s Office issues draft guidance for compliance with the GDPR’s contracting requirements.  

Since September, the Mintz Levin Privacy Webinar Series has focused on the upcoming EU General Data Protection Regulation (GDPR) to help businesses understand the reach and scope of the GDPR and prepare for the potentially game-changing privacy regulation. The GDPR will affect how US businesses handle and process personal data originating in the EU and may require changes to business process.

Access, Correction and Erasure: How to Minimize the Burden (2/16/2017)

This webinar, the sixth and final in our EU General Data Protection Regulation Series, considers companies’ obligations to give individuals access to their data and to correct or erase it.  We explore the new data portability requirements. The webinar concludes with some suggestions on how to make these requirements less burdensome.

Transferring Data from the EU (1/12/2017)

This webinar, the fifth in our EU General Data Protection Regulation Series, explores the ways in which the Regulation creates new avenues for data transfers, and narrows others. In particular, we consider sector-specific Commission decisions, privacy seals/certifications, the exception for non-repetitive, limited transfers, and the outlook for BCRs and Model Clauses.

Data Protection Officers: Do You Need One? (12/15/2016)

This webinar, the fourth in our EU General Data Protection Regulation Series, examines the criteria that dictate whether or not your organization needs to appoint a Data Protection Officer. We discuss the role of the DPO, the significance of the “independence” requirement, and the qualifications required to hold the position.

Good-bye to the Cure-all: The New Rules on Consent (11/10/2016)

This webinar, the third in our EU General Data Protection Regulation Series, reviews the new restrictions on relying on user consent to data processing and data transfers. In addition to the general “imbalance of power” problem, we consider the implications of the Directive on unfair terms in consumer contracts and changes that may need to be made to terms of use and privacy policies when dealing with consumers.

Accountability, Data Security, Data Impact Assessments and Breach Notification Requirements (10/13/2016)

This webinar, the second in our EU General Data Protection Regulation Series, focuses on the data security and accountability requirements of the Regulation, including reviews and documentation of internal policies and procedures and data impact assessments. We also explore the breach notification requirements and actions that companies can take in advance to mitigate the need for breach notification.

One-Stop Shopping Mall? The New Regulatory Structure (9/14/2016)

This webinar, the first in our EU General Data Protection Regulation Series, explains the powers and role of the new European Data Protection Board, how a “lead supervisory authority” will be designated for each controller, and how the lead supervisory authority will interact with other interested supervisory authorities. We also look at the complaint process from the point of view of the individual who is claiming a violation, and explore the likely role that will be played by public interest organizations bringing group complaints.

The European Union’s General Data Protection Regulation (the “GDPR”) goes into effect in a little over fourteen months and from a quick glance at our bullet points analysis you can see there is a lot to consider.  One crucial aspect you need to be thinking about now is how your organization collects and manages consents from individuals for processing their personal information.  Without a strong understanding of what valid consent means under the GDPR, before long you may find yourself holding valuable data that you are not able to process as you need to for your business.

To this end, the Information Commissioner’s Office (the “ICO”), the data protection authority for the UK, last week published a consultation draft of its GDPR consent guidance.  This is a practical resource meant to help organizations get to grips with the GDPR’s consent requirements and align their internal procedures and processing activities, as well as their customer-facing websites, marketing materials, and product infrastructure.   Although the UK ICO cannot speak for the other EU data protection authorities, they have a good track record of producing practical guidance set out in accessible language, which makes the ICO website a good first stop for US companies seeking to understand their obligations in the EU.  We encourage you to review this helpful resource and provide feedback to the ICO using their comment form by March 31.  We also offer this high-level snapshot of a few key points: Continue Reading It’s Not Too Early! ICO Guidance Regarding Consent Under GDPR