Article 29 Working Party Releases Guideline WP259 on Consent under the GDPR

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The Article 29 Working Party (WP29) released two guideline documents, WP259 and WP260, on the General Data Protection Regulation (GDPR) concepts of consent and transparency in November.  Comments on both documents will be accepted by the Working Party through January 23, 2018 after which the WP29 will issue final guidance.   WP29 is an independent European advisory body on data protection and privacy.

This blog post focuses on WP259, which is the guideline on consent. We have also written a companion blog on WP260, the guideline on transparency.

Guideline on Consent

The guideline provides a thorough analysis of the notion of consent, which is one of the six lawful bases to process personal data under the GDPR. Article 4(11) stipulates that consent of the data subject must be:

  • Freely given.
  • Specific.
  • Informed.
  • Unambiguous indication of the data subject’s wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her.

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Georgetown Law Center Releases Report on Biometric Face Scans at Airport Departure Gates

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The Georgetown Law Center for Privacy & Technology released a report that takes a harsh look at the Department of Homeland Security (DHS)’s “Biometric Exit” program.  The “Not Ready for Takeoff: Face Scans at Airport Departure Gates” report  highlights the myriad number of privacy and fairness issues associated with the use of biometric data for screening and other purposes.   The Biometric Air Exit program uses biometric data to verify travelers’ identities as they leave the U.S. and has been deployed at Boston’s Logan International Airport and eight other airports.  The program is operated by DHS and uses photographs of passengers taken at the gate while boarding to verify travelers’ identities as they leave the country.  Prior to departure of an outbound international flight, DHS prepopulates the Traveler Verification Service (TVS) with biometric templates from the travelers expected on the flight.  TVS either confirms the travelers face or rejects the face as a “non-match.”  Non-matched travelers credentials will then be checked manually.

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CMS Confirms Policy on Texting Patient Information among Healthcare Providers

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The Centers for Medicare & Medicaid Services (CMS) recently issued a State Survey & Certification Memorandum effective immediately in order to clarify its position on texting patient information among health care providers.

Although CMS acknowledges that the use of texting to communicate with other members of a patient’s health care team has become a common and invaluable practice, it acknowledges that such practice risks noncompliance with the Medicare Conditions of Participation (CoPs) or Conditions for Coverage (CfCs).  In order to text and comply with the CoPs or CfCs, CMS requires providers to use, maintain, and routinely assess secure, encrypted systems or platforms and minimize the risks to patient privacy and confidentiality per the Health Insurance Portability and Accountability Act and other requirements under the CoPs or CfCs.

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Oncology Services Provider Reaches $2.3 Million Settlement with HHS for Data Breach

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21st Century Oncology, Inc. (21CO), a Florida-based oncology services provider, has agreed to pay $2.3 million in a no-fault resolution to the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) to settle potential civil money penalties stemming from a 2015 cyberattack on its network SQL database.  The Federal Bureau of Investigation (FBI) was first to detect that an unauthorized third party illegally obtained patient information from 21CO in October 2015.  Upon further investigation by 21CO and OCR, it was determined that 21CO:

  • Impermissibly disclosed the protected health information (PHI), including names, social security numbers, and diagnoses, and treatments, of 2,213,597 of its patients.   
  • Failed to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of the electronic protected health information (ePHI).   
  • Failed to implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level.   
  • Failed to implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports.   
  • Disclosed protected health information to  third party vendors, acting as its business associates, without obtaining satisfactory assurances in the form of a written business associate agreement.

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Recent OCR Action Provides HIPAA Guidance Related to Opioid Crisis and Privacy Rule in Research

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The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently released several new tools and guidance to ensure that patients and their family members can gain access to information needed to prevent and address opioid abuse and overdose, as well as mental health crises. The materials are focused on the Health Insurance Portability and Accountability Act (HIPAA) and also serve to fulfill certain clarification requirements on HIPAA and research under the 21st Century Cures Act (the “Cures Act”).  The Cures Act was passed by Congress in 2016 and requires, in part, that “health care providers, professionals, patients and their families, and others involved in mental [health] or substance use disorder treatment have adequate, accessible, and easily comprehensible resources relating to appropriate uses and disclosures of protected health information (PHI) under . . . [HIPAA].”

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EU May Soon Decide “Adequate” Status for Japan

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The European Union (EU) may soon decide whether Japan will have “adequate” status for transfers of personal data from the EU.  Reuters reported on December 15, 2017 that the European Union is aiming to finalize a data transfer agreement with Japan by early 2018.

Set to be implemented in May 2018, the EU’s General Data Protection Regulation (GDPR) will require that EU citizens’ personal data be transferred to only countries  with an adequate data protection status, forbidding companies from storing EU citizens’ personal data in foreign countries deemed to have an “inadequate” level of privacy protection.

Under the EU’s privacy framework, the European Commission has the power to determine, based on Article 25(6) of Directive 94/46/EC, whether a foreign country has an “adequate” level of data protection under that country’s domestic laws or international commitments.  If a foreign country is deemed adequate, personal data can flow from the 28 EU countries (and three EEA member countries of Norway, Liechtenstein, and Iceland) to the foreign country without further safeguards.

The commission has so far deemed only 12 countries – Andorra, Argentina, Canada, Switzerland, Faeroe Islands, Guernsey, Israel, Isle of Man, Jersey, New Zealand, the United States (under the EU-US Privacy Shield), and Uruguay – as providing adequate protection.  The EU does not include the United States among its adequate protection countries. But Decision 2016/1250 on the adequacy of protection of the EU-US Privacy shield, commonly known as the EU-US Privacy Shield, was designed as a program whereby participating US companies or companies doing business in the US are deemed to have adequate protection.

An adequacy determination for Japan would be monumental for Japanese companies and companies doing business in Japan, with EU Justice Commissioner Vera Jourova recently stating that”[a]n adequacy decision would be great news for business as it would allow for the transfer of personal data from the EU to Japan without the need for extra authorisations.”

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