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Security, Privacy and Information Governance

Category: Privacy



Connecticut Supreme Court Establishes Private Right to Sue Over Medical Record Breaches

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The Connecticut Supreme Court has joined several other states by holding that health care providers owe patients a common law duty to maintain the confidentiality of their medical records. In a unanimous reversal of the lower court’s ruling, the court determined that the unauthorized disclosure of confidential information obtained in the course of a physician-patient relationship gives rise to a cause of action in tort against the health care provider, unless the disclosure is otherwise allowed by law.

Emily Byrne sued the Avery Center for Obstetrics and Gynecology, P.C. (“Avery”) for negligence and negligent infliction of emotional distress in connection with Avery’s release of her medical records in response to a subpoena issued by her ex-boyfriend, Andro Mendoza, in the course of a paternity action.  The subpoena instructed Avery to send the custodian of its records to appear, together with Byrne’s medical records, at the New Haven Regional Children’s Probate Court.  Avery did not alert Bryne about the subpoena, file a motion to quash it, or appear in court – it mailed Byrne’s medical records.  Bryne alleges that she suffered harassment and extortion threats from Mendoza because Avery gave him access to her medical records without her knowledge or consent.

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VTech Settlement Resolves COPPA Allegations in FTC’s First Connected Toy Case

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The Federal Trade Commission announced a settlement with VTech Electronics Limited and its U.S. subsidiary in the FTC’s first case involving Internet-connected toys.

VTech had been charged with violating the FTC Act and the Children’s Online Privacy Protection Act (COPPA) by collecting personal information from children without providing direct notice and obtaining their parent’s consent, as well as failing to properly secure the data it collected.  The settlement includes a payment of $650,000 in civil penalties, injunctive relief, and the establishment of a comprehensive security program.

Background

VTech, a Hong Kong corporation, and VTech Electronics North America, advertise, market and distribute electronic learning products (ELPs).  The companies offer online games available through the ELPs and operate the Learning Lodge Navigator online service, a platform similar to an app store that allows customers to download child-directed apps, games, e-books and other online content.  As of November 2015, approximately 2.25 million parents had created accounts with Learning Lodge for nearly 3 million children, according to the FTC.

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Article 29 Working Party Releases Guideline WP260 on Transparency 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.  Comments on both documents will be accepted by the Working Party through January 23, 2018 after which the WP 29 working party will issue final guidance. WP29 is an independent European advisory body on data protection and privacy.

This blog post focuses on WP260, the guideline on transparency. Our companion post on WP259, the guideline on consent can be read here.

Transparency has long been a fundamental feature of EU privacy law and is an overarching obligation under the GDPR. The draft guideline notes that a central consideration of the principle of transparency is that the data subject should be able to determine in advance what the scope and consequences of the processing entails. Transparency applies in three central areas:

  • The provision of information to data subjects related to the fair processing of their personal data.
  • How data controllers communicate with data subjects in relation to their rights under the GDPR.
  • How data controllers facilitate the exercise by data subjects of their rights.

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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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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.

In addition to the fine, 21CO agreed to enter into a two-year corrective action plan (CAP) with HHS-OCR whereby 21CO agrees to:

  • Appoint a compliance officer.
  • Complete a risk analysis and risk management plan.
  • Revise and adopt policies and procedures.
  • Provide HHS with an accounting and copies of its business associate agreements.
  • Conduct internal and external monitoring.
  • Create an internal reporting mechanism for workforce members to report violations of 21CO’s policies and procedures.
  • Submit to HHS an annual report for the duration of the CAP that summarizes its compliance with the aforementioned requirements.

This resolution and corrective action plan is the first OCR-HIPAA compliance enforcement action since May 2017.   It underscores the importance of having a robust HIPAA compliance program that properly assesses vulnerabilities and mitigates them to a reasonable and appropriate level.  The settlement was approved by the United States Bankruptcy Court for the Southern District of New York on December 11, 2017. 21CO has 136 centers located across 17 states and 36 centers in seven Latin American countries and had petitioned for bankruptcy on May 25, 2017,

The OCR settlement comes on the heels of two other major settlements for 21CO.  On March 8, 2016, 21CO entered into a settlement agreement with the U.S. Department of Justice (DOJ) for $34.7 million over a billing fraud case, and most recently settled with the DOJ on December 12, 2017 for $26 million to settle  False Claims Act allegations.   

If you have questions about HIPAA compliance or health care fraud and abuse matters, please feel free to contact any member of Drinker Biddle’s Health Care Team.

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