Privacy & Information Security Law Blog

The U.S. Department of Health and Human Services (“HHS”) recently announced the publication of “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (the “Cybersecurity Practices”). The Cybersecurity Practices were developed by the Healthcare & Public Health Sector Coordinating Councils Public Private Partnership, a group comprised of over 150 cybersecurity and healthcare experts from government and private industry.

On October 22, 2018, the Centre for Information Policy Leadership (“CIPL”) at Hunton Andrews Kurth LLP co-hosted a workshop in Brussels on “Can GDPR Work for Health Scientific Research?” (the “Workshop”) with the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) and the Future of Privacy Forum (“FPF”) to address the challenges raised by the EU General Data Protection Regulation (“GDPR”) in conducting scientific health research.

On October 30, 2018, ATA Consulting LLC (doing business as Best Medical Transcription) agreed to a $200,000 settlement with the New Jersey Attorney General resulting from a server misconfiguration that allowed private medical records to be posted publicly online. The fine was suspended to $31,000 based on the company’s financial condition. Read the settlement.

Recently, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement and record settlement of $16 million with Anthem, Inc. (“Anthem”) following Anthem’s 2015 data breach. That breach, affecting approximately 79 million individuals, was the largest breach of protected health information (“PHI”) in history.

On August 15, 2018, U.S. District Judge Lucy Koh signed an order granting final approval of the record $115 million class action settlement agreed to by Anthem Inc. in June 2017. As previously reported, Judge Koh signed an order granting preliminary approval of the settlement in August 2017.

In its most recent cybersecurity newsletter, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) provided guidance regarding identifying vulnerabilities and mitigating the associated risks of software used to process electronic protected health information (“ePHI”). The guidance, along with additional resources identified by OCR, are outlined below:

On June 6, 2018, the U.S. Court of Appeals for the Eleventh Circuit vacated a 2016 Federal Trade Commission (“FTC”) order compelling LabMD to implement a “comprehensive information security program that is reasonably designed to protect the security, confidentiality, and integrity of personal information collected from or about consumers.” The Eleventh Circuit agreed with LabMD that the FTC order was unenforceable because it did not direct the company to stop any “unfair act or practice” within the meaning of Section 5(a) of the Federal Trade Commission Act (the “FTC Act”).

The Department of Health and Human Services (“HHS”) recently published two advance notices of proposed rulemaking that address the accounting of disclosures and the potential distribution of civil monetary penalties to affected individuals.

On February 13, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it entered into a resolution agreement with the receiver appointed to liquidate the assets of Filefax, Inc. (“Filefax”) in order to settle potential violations of HIPAA. Filefax offered medical record storage, maintenance and delivery services for covered entities, and had gone out of business during the course of OCR’s investigation. 

On February 1, 2018, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a settlement with dialysis clinic operator, Fresenius Medical Care (“Fresenius”). Fresenius will pay OCR $3.5 million to settle claims brought under Health Insurance Portability and Accountability Act rules, alleging that lax security practices led to five breaches of electronic protected health information.

On January 23, 2018, the New York Attorney General announced that Aetna Inc. (“Aetna”) agreed to pay $1.15 million and enhance its privacy practices following an investigation alleging it risked revealing the HIV status of 2,460 New York residents by mailing them information in transparent window envelopes. In July 2017, Aetna sent HIV patients information on how to fill their prescriptions using envelopes with large clear plastic windows, through which patient names, addresses, claims numbers and medication instructions were visible. Through this, the HIV status of some patients was visible to third parties. The letters were sent to notify members of a class action lawsuit that, pursuant to that suit’s resolution, they could purchase HIV medications at physical pharmacy locations, rather than via mail order delivery.

As reported in BNA Privacy Law Watch, on December 6, 2017, health care provider 21st Century Oncology agreed to pay $2.3 million to settle charges by the Department of Health and Human Services' (“HHS”) Office for Civil Rights (“OCR”) that its security practices led to a data breach involving patient information. The settlement was made public in the company’s December 6, 2017, bankruptcy filing. The HHS charges stemmed from a 2015 data breach involving the compromise of Social Security numbers, medical diagnoses and health insurance information of at least 2.2 million ...

On October 3, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) issued an announcement clarifying when protected health information (“PHI”) can be shared with family, friends and others. This announcement, prompted by the recent mass shooting in Las Vegas, outlines the purposes for which PHI can be disclosed to these parties pursuant to HIPAA and the conditions that apply, which are summarized below:

On September 7, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) issued an announcement containing disaster preparedness and recovery guidance in advance of Hurricane Irma. The announcement follows a bulletin issued in late August during Hurricane Harvey that addressed how protected health information (“PHI”) can be shared during emergencies. Together, these communications underscore key privacy and security issues for entities covered by HIPAA to help them protect individuals’ health information before, during and after emergency situations.

On September 5, 2017, the FTC announced that Lenovo, Inc. (“Lenovo”) agreed to settle charges that its preloaded software on some laptop computers compromised online security protections in order to deliver advertisements to consumers. The settlement agreement (the “Settlement”) is between Lenovo, the FTC and 32 State Attorneys General. 

On August 25, 2017, U.S. District Judge Lucy Koh signed an order granting preliminary approval of the record class action settlement agreed to by Anthem Inc. this past June. The settlement arose out of a 2015 data breach that exposed the personal information of more than 78 million individuals, including names, dates of birth, Social Security numbers and health care ID numbers. The terms of the settlement include, among other things, the creation of a pool of funds to provide credit monitoring and reimbursement for out-of-pocket costs for customers, as well as up to $38 million in attorneys’ fees. Anthem will also be required to make certain changes to its data security systems and cybersecurity practices for at least three years.

On August 1, 2017, a unanimous three-judge panel for the D.C. Circuit reversed the dismissal of a putative data breach class action against health insurer CareFirst, Attias v. CareFirst, Inc., No. 16-7108, slip op. (D.C. Cir. Aug. 1, 2017), finding the risk of future injury was not too speculative to establish injury in fact under Article III. 

On July 25, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced the release of an updated web tool that highlights recent data breaches of health information.

On June 26, 2017, Airway Oxygen, a provider of oxygen therapy and home medical equipment, reported that it was the subject of a ransomware attack affecting 500,000 patients’ protected health information. The attack is the second largest health data breach recorded by the Office for Civil Rights (“OCR”) this year, and the largest ransomware incident recorded by OCR since it began tracking incidents in 2009.

On June 23, 2017, Anthem Inc., the nation’s second largest health insurer, reached a record $115 million settlement in a class action lawsuit arising out of a 2015 data breach that exposed the personal information of more than 78 million people. Among other things, the settlement creates a pool of funds to provide credit monitoring and reimbursement for out-of-pocket costs for customers, as well as up to $38 million in attorneys’ fees.

The U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) and the Health Care Industry Cybersecurity Task Force (the “Task Force”) have published important materials addressing cybersecurity in the health care industry.

On May 10, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a $2.4 million civil monetary penalty against Memorial Hermann Health System (“MHHS”) for alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule. 

On April 24, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it had entered into a resolution agreement with CardioNet, Inc. (“CardioNet”) stemming from gaps in policies and procedures uncovered after CardioNet reported breaches of unsecured electronic protected health information (“ePHI”). CardioNet provides patients with an ambulatory cardiac monitoring service, and the settlement is OCR’s first with a wireless health services provider.

On April 12, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement with Metro Community Provider Network (“MCPN”) that stemmed from MCPN’s lack of a risk analysis and risk management plan that addressed risks and vulnerabilities to protected health information (“PHI”).

On April 4, 2017, the Massachusetts Attorney General’s office announced a settlement with Copley Advertising LLC (“Copley”) in a case involving geofencing.

On February 17, 2017, Horizon Blue Cross Blue Shield of New Jersey (“Horizon”) agreed to pay $1.1 million as part of a settlement with the New Jersey Division of Consumer Affairs (the “Division”) regarding allegations that Horizon did not adequately protect the privacy of nearly 690,000 policyholders.

On February 16, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement with Memorial Healthcare System (“Memorial”) that emphasized the importance of audit controls in preventing breaches of protected health information (“PHI”). The $5.5 million settlement with Memorial is the fourth enforcement action taken by OCR in 2017, and matches the largest civil monetary ever imposed against a single covered entity.

On February 1, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a $3.2 million civil monetary penalty against Children’s Medical Center of Dallas (“Children’s”) for alleged ongoing violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy and Security Rules, following two consecutive breaches of patient electronic protected health information (“ePHI”). This is the third enforcement action taken by OCR in 2017, following the respective actions taken against MAPFRE Life Insurance of Puerto Rico and Presence Health earlier in January.

On January 18, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement with MAPFRE Life Insurance Company of Puerto Rico (“MAPFRE”) relating to a breach of protected health information (“PHI”) contained on a portable storage device. This is the second enforcement action taken by OCR in 2017, following the action taken against Presence Health earlier this month for failing to make timely breach notifications.

On January 7, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement with Presence Health stemming from the entity’s failure to notify affected individuals, the media and OCR within 60 days of discovering a breach. This marks the first OCR settlement of 2017 and the first enforcement action relating to untimely breach reporting by a HIPAA covered entity.

On November 22, 2016, the Department of Health and Human Services (“HHS”)  announced a $650,000 settlement with University of Massachusetts Amherst (“UMass”), resulting from alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy and Security Rules. 

Earlier this month, the Department of Health and Human Services’ Office for Civil Rights issued guidance (the “Guidance”) for HIPAA-covered entities that use cloud computing services involving electronic protected health information (“ePHI”).

On September 23, 2016, the French Data Protection Authority ("CNIL") published the results of the Internet sweep on connected devices. The sweep was conducted in May 2016 to assess the quality of the information provided to users of connected devices, the level of security of the data flows and the degree of user empowerment (e.g., user’s consent and ability to exercise data protection rights).

On August 4, 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement with Advocate Health Care Network (“Advocate”), the largest health care system in Illinois, over alleged HIPAA violations. The $5.5 million settlement with Advocate is the largest settlement to date against a single covered entity.

On July 29, 2016, the Federal Trade Commission (“FTC”) announced that it had issued an opinion and final order concluding that LabMD, Inc. (“LabMD”) violated the unfairness prong of Section 5 of the FTC Act by failing to maintain reasonable security practices to protect consumers’ sensitive personal information. The unanimous decision reverses a November 2015 administrative law judge’s initial decision that, as we previously reported, dismissed the FTC’s charges against LabMD for failing to show that LabMD’s allegedly unreasonable data security practices caused, or were likely to cause, substantial consumer injury.

On July 21, 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into resolution agreements with two large public health centers, Oregon Health & Science University (“OHSU”) and the University of Mississippi Medical Center (“UMMC”), over alleged HIPAA violations.

On July 6, 2016, the UK government decided to close its controversial care.data scheme after concerns were raised about the safeguards in place to protect individuals’ health care data and issues with patient transparency.

On June 30, 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it had settled potential HIPAA Security Rule violations with Catholic Health Care Services of the Archdiocese of Philadelphia (“CHCS”). This is the first enforcement action OCR has taken against a business associate since the HIPAA Omnibus Rule was enacted in 2013. The HIPAA Omnibus Rule made business associates directly liable for their violations of the HIPAA rules. The settlement with CHCS is also notable because it involved a breach that affected fewer than 500 individuals.

On June 8, 2016, the Federal Trade Commission announced that Practice Fusion, an electronic health records company, agreed to settle FTC charges that the company misled consumers about the privacy of doctor reviews submitted to the company.

On May 19, 2016, Hunton & Williams LLP and The Advisory Board Company hosted a webinar on How to Discuss Cybersecurity with Your C-Suite and Board of Directors. Hunton partner Matthew Jenkins moderated the session, and speakers included partner Paul Tiao, member of the firm’s Global Technology and Privacy practice, and The Advisory Board Company’s Chief Information Security Officer and Senior Research Director. Together, they provided insight and advice on how to have a productive conversation about security and risk with the most senior leaders in a health care ...

Recently, Aegerion Pharmaceuticals announced that it will enter into several settlements and plead guilty to two misdemeanors in connection with alleged violations of HIPAA, drug marketing regulations and securities laws. The criminal charges stem from the company’s marketing of a cholesterol drug called Juxtapid. Aegerion allegedly failed to comply with risk evaluation and management strategies and marketed Juxtapid (which is labeled with a warning about liver toxicity) without proper directions for use. 

The U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently announced resolution agreements with Raleigh Orthopaedic Clinic, P.A., (“Raleigh Orthopaedic”) and New York-Presbyterian Hospital (“NYP”) for HIPAA Privacy Rule violations.

The Federal Trade Commission recently released an interactive tool for mobile health apps. The tool was developed in conjunction with several other federal agencies, including the Department of Health and Human Services’ Office for Civil Rights, the Office of the National Coordinator for Health Information Technology, and the Food and Drug Administration.

On March 16, 2016, and March 17, 2016, respectively, the Department of Health and Human Services (“HHS”) announced resolution agreements with North Memorial Health Care of Minnesota (“North Memorial”) and The Feinstein Institute for Medical Research (“Feinstein Institute”) over potential violations of the HIPAA Privacy Rule.

On March 21, 2016, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it has commenced Phase 2 of the HIPAA Audit Program. Phase 1 of the HIPAA Audit Program ran from 2011-2012 and produced several notable findings, including that two-thirds of covered entities had not performed a risk assessment as required by the HIPAA Security Rule.

Recently, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) published two guidance documents related to HIPAA compliance. To help mobile app developers understand HIPAA compliance obligations, OCR published guidance on the use of mobile health apps (the “Health App Guidance”). OCR also released a crosswalk (the “Crosswalk”) that maps the National Institute of Standards and Technology (“NIST”) Framework for Improving Critical Infrastructure Cybersecurity Framework (the “NIST Cybersecurity Framework”) to the HIPAA Security Rule.

On February 3, 2016, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced that an Administrative Law Judge (“ALJ”) ruled that Lincare, Inc. (“Lincare”) violated the HIPAA Privacy Rule and ordered the company to pay $239,800 to OCR.

On January 5, 2016, the Federal Trade Commission announced that dental office management software provider, Henry Schein Practice Solutions, Inc. (“Schein”), agreed to settle FTC charges that accused the company of falsely advertising the level of encryption it used to protect patient data. The proposed Agreement Containing Consent Order (“Consent Order”) stems from an FTC complaint that alleged the company engaged in unfair or deceptive acts or practices by falsely representing that the Dentrix G5 software used industry-standard encryption and helped dentists protect patient data in accordance with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

On December 14, 2015, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that it had settled potential HIPAA Security Rule violations with the University of Washington on behalf of the university’s medical center, medical school and affiliated labs and clinics (collectively, “UW Medical”).

On November 30, 2015, the U.S. Department of Health and Human Services (“HHS”) announced that Triple-S Management Corporation ("Triple-S"), an insurance holding company based in San Juan, Puerto Rico, agreed on behalf of certain of its subsidiaries to settle potential violations of the HIPAA Privacy and Security Rules with HHS’s Office for Civil Rights (“OCR”).

On July 1, 2015, Connecticut’s governor signed into law Public Act No. 15-142, An Act Improving Data Security and Agency Effectiveness (the “Act”), that (1) amends the state’s data breach notification law to require notice to affected individuals and the Connecticut Attorney General within 90 days of a security breach and expands the definition of personal information to include biometric data such as fingerprints, retina scans and voice prints; (2) affirmatively requires all businesses, including health insurers, who experience data breaches to offer one year of identity theft prevention services to affected individuals at no cost to them; and (3) requires health insurers and contractors who receive personal information from state agencies to implement and maintain minimum data security safeguards. With the passing of the Act, Connecticut becomes the first state to affirmatively require businesses to provide these security services to consumers.

On July 10, 2015, the United States House of Representatives passed the 21st Century Cures Act (the “Act”), which is intended to ease restrictions on the use and disclosure of protected health information (“PHI”) for research purposes.

The Department of Health and Human Services (“HHS”) recently announced a resolution agreement and $125,000 settlement with Cornell Prescription Pharmacy (“Cornell”) in connection with the disposal of prescription records in an unsecured dumpster on Cornell’s premises. After receiving a report from a Denver television station regarding Cornell’s disposal practices, the HHS’ Office for Civil Rights (“OCR”) investigated Cornell and found several HIPAA Privacy Rule violations, including that Cornell had failed to:

On April 8, 2015, a New York Assemblyman introduced the Data Security Act in the New York State Assembly that would require New York businesses to implement and maintain information security safeguards. The requirements would apply to “private information,” which is defined as either:

• personal information consisting of any information in combination with one or more of the following data elements, when either the personal information or the data element is not encrypted: Social Security number; driver’s license number or non-driver identification card number; financial account or credit or debit card number in combination with any required security code or password; or biometric information;
• a user name or email address in combination with a password or security question and answer that would permit access to an online account; or
• unsecured protected health information (as that term is defined in the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule).

On February 5, 2015, the Article 29 Working Party (the “Working Party”) published a letter that responds to a request of the European Commission to clarify the scope of the definition of health data in connection with lifestyle and wellbeing apps. In the annex to this letter, the Working Party identifies criteria to determine when personal data qualifies as “health data,” a special category of data receiving enhanced protection under the EU Data Protection Directive 95/46/EC (the “Directive”). The Working Party further discusses the current legal regime for the processing of such health data and provides its view on the requirements for further processing of health data for historical, statistical and scientific research under the Directive. The letter also includes the Working Party’s recommendations for the regime that should be provided in the proposed EU General Data Protection Regulation (the “Proposed Regulation”).

On January 27, 2015, the Federal Trade Commission announced the release of a report on the Internet of Things: Privacy and Security in a Connected World (the “Report”). The Report describes the current state of the Internet of Things, analyzes the benefits and risks of its development, applies privacy principles to the Internet of Things and discusses whether legislation is needed to address this burgeoning area. The Report follows a workshop by the FTC on this topic in November 2013.

The Department of Health and Human Services (“HHS”) recently announced a resolution agreement and $150,000 settlement with Anchorage Community Mental Health Services, Inc. (“ACHMS”) in connection with a data breach caused by malware. ACHMS, which provides nonprofit behavioral health care services in Alaska, experienced a breach in March 2012 that affected the electronic protected health information (“ePHI”) of 2,743 individuals. After ACHMS reported the breach to the HHS Office for Civil Rights (“OCR”), OCR investigated ACHMS and found several HIPAA Security Rule violations, including that ACHMS had failed to:

On November 21, 2014, Massachusetts Attorney General Martha Coakley announced that Boston hospital Beth Israel Deaconess Medical Center (“BIDMC”) has agreed to pay a total of $100,000 to settle charges related to a data breach that affected the personal and protected health information of nearly 4,000 patients and employees.

Hunton & Williams Labor & Employment partner Susan Wiltsie reports:

Fears of a worldwide Ebola pandemic appear to have abated, but the tension between workplace safety and employee privacy, thrown into relief by this health emergency, remains an issue relevant to all employers. Any potential health threat created by contagious illness requires employers to plan and put into effect a reasonable response, including policies governing the terms and conditions under which employees may be required to stay away from the workplace, and in which their health care information may be relevant to workplace decisions.

On October 1, 2014, the Food and Drug Administration (“FDA”) announced that it has issued final guidance regarding cybersecurity in medical devices, entitled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (the “Guidance”). The Guidance provides recommendations to device manufacturers for content “to include in FDA medical device premarket submissions for effective cybersecurity management.” The Guidance updates a draft guidance that was originally published in June 2013.

On July 1, 2014, Delaware Governor Jack Markell signed into law a bill that creates new safe destruction requirements for the disposal of business records containing consumer personal information. The new law requires commercial entities conducting business in Delaware to take reasonable steps to destroy their consumers’ “personal identifying information” prior to the disposal of electronic or paper records. The law will take effect on January 1, 2015.

On June 20, 2014, Florida Governor Rick Scott signed a bill into law that repeals and replaces the state’s existing breach notification statute with a similar law entitled the Florida Information Protection Act (Section 501.171 of the Florida Statutes) (the “Act”).

On June 23, 2014, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $800,000 settlement with Parkview Health System, Inc. (“Parkview”) following a complaint involving patient medical records that were dumped by Parkview employees and left unattended on a physician’s driveway.

On June 12, 2014, Connecticut Governor Dannel Malloy signed a bill into law that may require retailers to modify their existing Health Insurance Portability and Accountability Act (“HIPAA”) authorizations for pharmacy reward programs. The law, which will become effective on July 1, 2014, obligates retailers to provide consumers with a “plain language summary of the terms and conditions” of their pharmacy reward programs before the consumers may enroll. It also requires retailers to include specific content in their authorization forms that are required pursuant to the HIPAA. If the consumer is required to sign a HIPAA authorization to participate in a pharmacy reward program, the authorization must include the following items “adjacent to the point where the HIPAA authorization form is to be signed:”

On May 7, 2014, the Department of Health and Human Services (“HHS”) announced that NewYork-Presbyterian Hospital (“NYP”) and Columbia University (“CU”) agreed to collectively pay $4.8 million in the largest HIPAA settlement to date, to settle charges that they potentially violated the HIPAA Privacy and Security Rules.

On April 23, 2014, the Department of Health and Human Services (“HHS”) announced settlements with two health care companies stemming from allegations of inadequate information security practices in the wake of investigations involving stolen laptop computers. Concentra Health Services (“Concentra”) and QCA Health Plan Inc. (“QCA”) will collectively pay nearly $2 million to settle the claims.

On March 28, 2014, the Department of Health and Human Services’ (“HHS’”) Office for Civil Rights (“OCR”) released a tool to assist covered entities in complying with the HIPAA Security Rule requirement to conduct a risk assessment. The HIPAA Security Rule obligates covered entities to accurately and thoroughly assess “the potential risks and vulnerabilities to the confidentiality, integrity and availability of electronic protected health information” (“PHI”) they maintain. The tool, which is aimed at small to medium health care providers, was developed jointly by OCR and the HHS Office of the National Coordinator for Health Information Technology (“ONC”), and follows the National Institute of Standards and Technology’s development of a similar toolkit.

The Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently announced that it intends to survey up to 1,200 covered entities and business associates to determine their suitability for a more fulsome HIPAA compliance audit. In a notice published in the Federal Register, OCR stated that the survey will collect information such as “number of patient visits or insured lives, use of electronic information, revenue, and business locations” to assess the organizations’ “size, complexity and fitness” for an audit.

On March 7, 2014, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $215,000 settlement with Skagit County, Washington, following a security breach that affected approximately 1,600 individuals.

The Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently released guidance about the use and disclosure of mental health information. The guidance, entitled “HIPAA Privacy Rule and Sharing Information Related to Mental Health,” contains thirteen questions and answers that address the following topics:

Triple-S Management Corporation reported in the 8-K it recently filed with the U.S. Securities and Exchange Commission that its health insurance subsidiary, Triple-S Salud, Inc. (“Triple S”), which is Puerto Rico’s largest health insurer, will be fined $6.8 million for a data breach that occurred in September 2013. The civil monetary penalty, which is being levied by the Puerto Rico Health Insurance Administration, will be the largest fine ever imposed following a breach of protected health information.

On December 31, 2013, the Federal Trade Commission announced that Accretive Health, Inc. (“Accretive”) has agreed to settle charges that the company’s inadequate data security measures unfairly exposed sensitive consumer information to the risk of theft or misuse. Accretive experienced a breach in July 2011 that involved the protected health information of more than 23,000 patients.

On December 26, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $150,000 settlement with Adult & Pediatric Dermatology, P.C. (“APDerm”), a private dermatology practice based in Massachusetts, following a security breach that affected approximately 2,200 individuals. In connection with the announcement, the HHS Office for Civil Rights (“OCR”) Director Leon Rodriguez stated that “[c]overed entities of all sizes need to give priority to securing electronic protected health information.”

On December 2, 2013, the Federal Trade Commission announced that it will host a series of seminars to examine the privacy implications of three new areas of technology used to track, market to and analyze consumers: mobile device tracking, predictive scoring and consumer-generated health data. The seminars will address (1) businesses tracking consumers using signals from the consumers’ mobile devices, (2) the use of predictive scoring to determine consumers’ access to products and offers, and (3) consumer-generated information provided to non-HIPAA covered websites and apps. The FTC stated that the intention of the seminars is to bring attention to new trends in big data and their impact on consumer privacy.

On November 19, 2013, the National Health and Family Planning Commission of the People’s Republic of China published a draft of its proposed new Administrative Measures on Personal Health Information (the “Draft Measures”) and solicited public comments by December 20, 2013.

On October 2, 2013, the 86th Conference of the German Data Protection Commissioners concluded in Bremen. This biannual conference provides a private forum for the 16 German state data protection authorities (“DPAs”) and the Federal Commissioner for Data Protection and Freedom of Information, Peter Schaar, to share their views on current issues, discuss relevant cases and adopt Resolutions aimed at harmonizing how data protection law is applied across Germany.

Today, September 23, 2013, marks the deadline for compliance with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Omnibus Rule that was issued in January 2013. Covered entities, business associates and subcontractors that access, use or disclose protected health information (“PHI”) will need to take the following actions:

This week, the Department of Health and Human Services’ Office for Civil Rights (“OCR”), in conjunction with the Office of the National Coordinator for Health Information Technology, released model Notices of Privacy Practices. The notices, which have been developed for use by health care providers and health plans, come in different formats:

• an 8-page booklet;
• a 5-page layered notice that summarizes key details on the first page and includes the full content of the booklet on the remaining four pages;
• a 5-page condensed version of the 8-page booklet; and
• a 6-page text-only version of the booklet.

On August 14, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $1,215,780 settlement with Affinity Health Plan (“Affinity”) stemming from a security breach that affected approximately 350,000 individuals.

On April 19, 2013, the North Dakota legislature amended the state’s breach notification law (Section 51-30-01 of the North Dakota Century Code) to expand the definition of “personal information” to include “health insurance information” and “medical information.” Pursuant to the amended breach law, “health insurance information” is defined to mean an “individual’s health insurance policy number or subscriber identification number and any unique identifier used by a health insurer to identify the individual.” “Medical information” is defined to mean “any information regarding an individual’s medical history, mental or physical condition, or medical treatment or diagnosis by a health care professional.” The amendment also carves out an exemption for covered entities, business associates and subcontractors that are subject to the breach notification requirements of 45 C.F.R. 164, Subpart D.

On July 12, 2013, Illinois Attorney General Lisa Madigan announced that she sent letters to operators of eight popular health-related websites requesting information about the websites’ online data collection practices. The Attorney General’s press release underscored how individuals’ health-related information shared online, which would be protected if disclosed in a traditional medical setting, “can be captured, shared and sold when online users enter their information into a website.” The Attorney General also stated that “website disclosure about the extent to which information is captured or shared is buried in privacy policies not found on the websites’ main pages.”

On July 11, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $1.7 million settlement with WellPoint Inc. following a security breach that affected over 600,000 individuals.

On June 28, 2013, the Swiss Federal Data Protection and Information Commissioner (“FDPIC”) issued its 20th annual Report of Activities (the “Report”), highlighting the FDPIC’s main activities during the period from April 2012 to March 2013. The Report is available in French and in German, and the FDPIC also has prepared a summary of the Report in English.

On June 13, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $275,000 settlement with Shasta Regional Medical Center (“Shasta”) that pertained to impermissible disclosures of protected health information (“PHI”) by Shasta officials to the media, as well as to Shasta’s entire workforce.

On June 13, 2013, the Food and Drug Administration (“FDA”) published a safety communication and guidance regarding the vulnerability of medical devices to cyberattacks. The safety communication, Cybersecurity for Medical Devices and Hospital Networks, is intended for “[m]edical device manufacturers, hospitals, medical device user facilities, health care IT and procurements staff; and biomedical engineers.” The safety communication notes that because medical devices can be connected to other devices and the Internet, such devices are exposed to cyber attacks that might result from malware infections, the exploitation of weak password protections, a lack of updated security patches and security vulnerabilities in software installed on medical devices.

On May 21, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $400,000 settlement with Idaho State University (“ISU”) for a breach that affected 17,500 individuals.

The ISU settlement relates to servers that had their firewall protections disabled, which left the electronic protected health information (“ePHI”) of patients at ISU’s Pocatello Family Medicine Clinic unsecured for at least ten months. Following the submission of a breach report to the HHS Office for Civil Rights (“OCR”), an investigation determined that ISU allegedly had not complied with HIPAA Security Rule requirements, including by conducting an incomplete and inadequate risk analysis and by failing to “adequately implement procedures to regularly review records of information system activity to determine if any ePHI was used or disclosed in an inappropriate manner.”

On April 17, 2013, the Federal Trade Commission issued a press release seeking public input on “The Internet of Things” – the ability of numerous “everyday devices to communicate with each other and with people.” The FTC will accept comments through June 1, 2013, in advance of a public workshop to be held in Washington, D.C. on November 21, 2013.

On April 9, 2013, the United States Court of Appeals for the Eleventh Circuit held that the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) preempted a Florida law regarding the disclosure of patient records by nursing homes. The law required nursing homes in Florida to provide the medical records of a deceased nursing home resident to the “spouse, guardian, surrogate, proxy, or attorney in fact,” including “medical and psychiatric records and any records concerning the care and treatment of the resident performed by the facility, except progress notes and consultation report sections of a psychiatric nature.”

On April 2, 2013, the Article 29 Working Party (the “Working Party”) adopted an Opinion (the “Opinion”) that elaborates on the purpose limitation principle set out in Article 6(1)(b) of the current EU Data Protection Directive 95/46/EC (the “Data Protection Directive”). The Opinion analyzes the scope of this principle under the Data Protection Directive, clarifies its limits and makes recommendations to strengthen it in the proposed General Data Protection Regulation (the “Proposed Regulation”). It also focuses on how to apply this principle in the context of Big Data and open data.

On January 17, 2013, the U.S. Department of Health and Human Services issued a final omnibus rule modifying prior regulations enacted pursuant to the Health Insurance Portability and Accountability Act of 1996. Among the key changes that will come into effect this September is the addition of a provision that dramatically increases the number of organizations directly subject to the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. In an article published in the March/April issue of Storage & Destruction Business Magazine, Lisa J. Sotto, partner and head of the ...

On January 28, 2013, the London office of Hunton & Williams marked European Data Privacy Day with the launch of the fourth edition of Data Protection Law & Practice, written by Senior Attorney Rosemary Jay. A panel comprised of the current UK Information Commissioner, Christopher Graham; his three predecessors, Eric Howe CBE, Elizabeth France CBE and Richard Thomas CBE; and the UK Minister of State for Justice, Lord McNally, spoke at the event and provided a retrospective on data protection in the United Kingdom since the Information Commissioner’s Office’s (“ICO’s”) inception in 1984.

On January 28, 2013, the Federal Trade Commission announced a proposed settlement agreement with CBR Systems, Inc. (“CBR”), an operator of a cord blood bank, which collects personal information about consumers and physicians through its websites and in connection with the provision of its services, including names, addresses, dates of birth, Social Security numbers, credit card numbers and health information.

The wait is over. On January 17, 2013, the Department of Health and Human Services’ (“HHS’”) Office for Civil Rights (“OCR”) released its long-anticipated megarule (“Omnibus Rule”) amending the HIPAA Privacy, Security, Breach Notification and Enforcement Rules. These amendments implement and expand on the requirements of the Health Information Technology for Economic and Clinical Health (“HITECH”) Act and the Genetic Information Nondiscrimination Act of 2008. The Omnibus Rule is effective March 26, 2013, and compliance is required with respect to most provisions no later than September 23, 2013. Coming into compliance will require significant effort and attention by covered entities and business associates alike. Below we highlight some of the more significant aspects of the Omnibus Rule and provide critical compliance tips.

On January 17, 2013, the Department of Health and Human Services (“HHS”) issued a Final Omnibus Rule modifying the Privacy, Security and Enforcement Rules promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as well as the Breach Notification Rule promulgated pursuant to the Health Information Technology for Economic and Clinical Health Act (the “HITECH” Act) enacted in 2009. The Final Rule comes two and a half years after the proposed rule was published in July 2010.

On January 7, 2013, Massachusetts Attorney General Martha Coakley announced that several Massachusetts medical practices have agreed to a consent judgment and $140,000 payment to settle charges they improperly disposed of medical information. The defendants, which include several pathology practices and a firm that provided medical billing services to those practices, were accused of dumping hard copy medical records at the Georgetown Transfer Station, a waste management facility open to the public. The records allegedly contained the names, Social Security numbers and medical diagnoses of approximately 67,000 individuals. The illegal dumping allegations were publicized in a Boston Globe article after a photographer for the newspaper discovered medical records at the facility while he was disposing of his own trash.

On January 2, 2013, the Department of Health and Human Services (“HHS”) announced a resolution agreement and $50,000 settlement with Hospice of North Idaho (“HONI”) for a breach that affected 441 individuals. This action is notable because prior HHS enforcement actions relating to breaches have involved a greater number of affected individuals (for example, the first breach-related enforcement action in March 2012 affected more than 1 million). The Health Information Technology for Economic and Clinical Health (“HITECH”) Breach Notification Rule sets 500 as a threshold number of affected individuals triggering certain notification requirements such as the obligation to notify HHS within 60 days of discovery of the breach.

In an interview with Marianne Kolbasuk McGee of HealthcareInfoSecurity, Lisa J. Sotto, partner and head of the Global Privacy and Data Security practice at Hunton & Williams LLP, discusses the measures health care organizations should take to prepare for the issuance of the upcoming HIPAA Omnibus Rule. In March 2012, the Department of Health and Human Services (“HHS”) sent its final Omnibus Rule modifying the HIPAA Privacy, Security and Enforcement Rules to the White House Office of Management and Budget. In the interview, Sotto outlines her predictions of the content of the Omnibus Rule, including “modifications to the HIPAA privacy, security and enforcement rules” and “a final version of the HIPAA breach notification rule.”

On November 26, 2012, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) published guidance on the two methods for de-identifying protected health information (“PHI”) in accordance with the HIPAA Privacy Rule. The guidance, which was required by the Health Information Technology for Clinical and Economic Health (“HITECH”) Act, has been developed over several years by OCR in collaboration with healthcare entities and other industry experts and builds upon the discussions from a workshop on de-identification that took place in March 2010.

On November 20, 2012, the UK Information Commissioner’s Office (“ICO”) published “Anonymisation: Managing Data Protection Risk Code of Practice” (the “Code”). The purpose of the Code is to provide organizations with a framework for assessing the risks of anonymization. It also sets forth good practice recommendations that may be adopted by organizations to provide a “reasonable degree of confidence” that the publication and sharing of anonymized data will not lead to an “inappropriate disclosure of personal data.” The published Code follows a consultation on the same topic earlier this year. The ICO also announced the creation of the UK Anonymisation Network, which will promote the sharing of good practices related to anonymization across the public and private sectors.

On October 15, 2012, the Singapore Parliament passed the Personal Data Protection Act 2012. Though a law has been under discussion for quite some time, this bill was introduced before Parliament only recently, in September of this year. The new law will apply only to data processing in the private sector as data processing by public agencies (or organizations acting on behalf of public agencies) are already subject to internal government rules. Reportedly, the bill will become law in January 2013, enforceable after 18 months, in mid-2014.