Back in 2008, Illinois became the first state to pass legislation specifically protecting individuals’ biometric data. Following years of legal challenges, some of the major questions about the law are about to be resolved (hopefully). Two major legal challenges, one now at the Illinois Supreme Court and another with the Court of Appeals for the Ninth Circuit, seek to clarify the foundational issues that have been a battleground for privacy litigation — standing and injury. To understand the stakes, Illinois’ Biometric Information Privacy Act requires companies who obtain a person’s biometric information to: (1) obtain a written release prior to their information being stored and collected; (2) provide notice that their information is being stored and collected; (3) state how long the information will be stored and used; and (4) disclose the specific purpose for its storage and use. The law further provides individuals with a private right of action. However, in order to trigger that private right, an individual must be “aggrieved.” Continue Reading Biometric Data Risks on the Rise

On December 4, 2018, New York Attorney General Barbara D. Underwood announced a $4.95 million settlement with Oath, Inc. (f/k/a AOL Inc.), a wholly-owned subsidiary of Verizon Communications, Inc., for alleged violations of the Children’s Online Privacy Protection Act (“COPPA”) as a result of its involvement with online behavioral advertising auctions. This settlement represents the largest penalty ever in a COPPA enforcement matter in U.S. history.

Through its investigation, the New York Attorney General’s Office discovered that AOL collected, used, and disclosed personal information of website users under the age of 13 without parental consent in violation of COPPA. Specifically, the company was charged with having “conducted billions of auctions for ad space on hundreds of websites the company knew were directed to children under the age of 13.” The New York Attorney General found that AOL operated several ad exchanges and permitted clients to use its display ad exchange to sell ad space on COPPA-covered websites, despite the fact that the exchange was not capable of conducting a COPPA-compliant auction that involved third-party bidders. AOL was charged with having knowledge that these websites were subject to COPPA because evidence demonstrated that: (i) several AOL clients had provided AOL with notice that their websites were subject to COPPA and (ii) AOL had conducted a review of the content and privacy policies of client websites and had designated certain websites as being child-directed. Additionally, the New York Attorney General charged AOL with having placed ads through other exchanges in violation of COPPA.   Specifically, whenever AOL participated and won an auction for ad space on a COPPA-covered website, AOL ignored any information it received from an ad exchange indicating that the ad space was subject to COPPA and collected information about the website users to serve a targeted advertisement to the users. Continue Reading Oath (f/k/a AOL) Agrees to Record $5 Million COPPA Settlement

A little more than six months after that day in May when privacy policy updates flooded our inboxes and the GDPR came into force, a new study of small business owners in the UK has found that many people and businesses remain essentially “clueless” about the law and its requirements. Commissioned by Aon, the study found that nearly half of the 1,000 small business owners polled are confused about the privacy and security requirements of the law, which could lead many businesses to be in breach of the GDPR without even realizing it. Some examples of potential violations reported by the businesses included paper visitor books logging all visitors to the business and viewable to subsequent visitors, training materials featuring full details of real-life case studies, the use of personal devices by employees for work purposes, and inadequate storage and disposal of paper records. The study also found that business owners were not clear on what constitutes a data breach – thinking the term did not apply to paper records or personal data that was mistakenly posted or sent to the wrong person by email or fax – nor were they clear on the notification requirements, either to the UK’s data protection authority, the Information Commissioner’s Office (“ICO”), or to affected individuals. These small business owners should avail themselves of the ICO’s recent insight into its GDPR enforcement approach from earlier this month, which indicates that ignorant non-compliance likely won’t be looked at favorably. Continue Reading GDPR Guidance and Other Goings-On

The Commerce Department’s Bureau of Industry and Security (“BIS”) recently published an advanced notice of proposed rulemaking asking for public comment on criteria to identify “emerging technologies that are essential to U.S. national security,” for example because they have potential intelligence collection applications or could provide the United States with a qualitative intelligence advantage.

BIS is the federal agency that primarily oversees commercial exports. Over the summer, Congress passed the Export Control Reform Act of 2018 and authorized BIS to establish appropriate controls on the export of emerging and foundational technologies. Although by no means exclusive or final, BIS has proposed an initial list of areas that may become “emerging technologies,” including artificial intelligence/machine learning technology, brain-computer interfaces, and advanced surveillance technology, such as faceprint and voiceprint technologies. If BIS ultimately determines a technology will be subject to export controls, it will likely receive a newly-created Export Control Classification Number on BIS’s Commerce Control List and would require a license before export to any country subject to a U.S. embargo, including arms embargos (e.g., China). Continue Reading Is Your Technology an “Emerging Technology?”

A few months ago we posted an update on the California Consumer Privacy Act, a mini-GDPR that contains serious privacy ramifications for the U.S. privacy landscape. Likely in response to the upcoming 2020 go-live for the California law, various groups have noticed an uptick in lobbying directed at the passage of a federal privacy law that would pre-empt the California law and help harmonize the various state laws. Pushing to the front of that effort is a new draft federal privacy law proposed by Intel.

The Intel law looks to be written specifically to pre-empt the California law, as it contains language that would pre-empt any State law with civil provisions designed to reduce privacy risk through the regulation of personal data. This pre-emption contains limited exceptions for state-data-breach, contract, consumer protection, and various other laws, but it would drive a hole through California’s law. Furthermore, Intel’s proposed law could pre-empt various specific laws such as Illinois biometric data protection law, and because it does not include any notice provision — it would be reliant on the state-breach-notification statutes to find violations in the first place.

Beyond frustrating state attempts at personal information regulation, the law creates penalty caps that result in disproportionate punishments for smaller and mid-size security incidents and allow larger incidents, typical of a larger company, to operate on an eat-the-fine basis. For example: The Equifax breach from earlier this year affected 143 million Americans. If regulators chose to bring an action, the maximum penalties for the action could be up to $16,500 per violation — that means a maximum penalty of 2.3 trillion dollars. The penalty cap however was set at 1 billion dollars, meaning the largest data breaches will face the lowest penalty-per-impacted individual.

Our take

This proposed national privacy law would primarily serve the interests of the largest players in the tech and data industry, while providing harsher relative penalties to smaller and mid-size players. This law or something similar is likely to see serious political debate in the next few years as lobbying efforts intensify. Expect the heat to turn up as we near January 1, 2020.

On October 18, 2018, the Food and Drug Administration (“FDA”) released draft guidance outlining its plans for the management of cybersecurity risks in medical devices. Commenters now have until March 17, 2019, to submit comments to the FDA and get their concerns on the record. More information about submitting comments can be found at the end of this post.

This FDA guidance revision will replace existing guidance released in 2014, which as you can see, includes recommendations, but does not attempt to classify devices. The recent draft guidance takes a more aggressive posture and separates devices into those with a Tier 1 “Higher Cybersecurity Risk” and those with a Tier 2 “Standard Cybersecurity Risk.”

Tier 1 devices are those that meet the following criteria:

1) The device is capable of connecting (e.g., wired, wirelessly) to another medical or non-medical product, or to a network, or to the Internet; and

2) A cybersecurity incident affecting the device could directly result in harm to multiple patients.

Tier 2 devices are any medical device that does not meet the criteria in Tier 1.

The FDA has varying guidance for devices depending on the Tier of the device. The FDA provides guidance for Tier 1 and Tier 2 devices on applying the NIST Cybersecurity Framework, providing appropriate cybersecurity documentation, and adhering to labeling recommendations.

Continue Reading FDA Releases Draft Guidance on Cybersecurity for Health Devices

In a recent letter to the Federal Trade Commission (“FTC”), Senators Edward J. Markey (D-Mass) and Richard Blumenthal (D-Conn), expressed their concern regarding a recent study, which “indicates that numerous apps directed at children have been accessing geolocation data and transmitting persistent identifiers without parental consent” in violation of the Children’s Online Privacy Protection Act of 1998 (“COPPA”). In addition, the senators voiced concerns that parents are being misled by app developers, the advertising companies they work with, and app stores because such apps are placed in the “kids” or “families” sections of app stores. In other words, these apps should not be marketed as appropriate for children if they are engaging in activity that violates COPPA. The senators urged the FTC to review the extent to which app developers, advertising companies, and app stores are complying with COPPA. The senators requested a response from the FTC by October 31.

The study referenced in the senators’ letter comprised of a review of 5,855 “child-friendly” apps for compliance with COPPA. The researchers found that approximately 57% of these apps were engaging in activity prohibited by COPPA. For example, the researchers concluded that over 1,000 of the apps analyzed shared persistent identifiers with third parties. Furthermore, they found that 235 of the apps analyzed accessed geolocation information without verifiable parental consent, with a number of apps also sharing this information with advertising companies.

A copy of the senators’ letter to the FTC can be found here.

Our take

COPPA was designed to protect children under the age of 13 from overreaching by marketers by providing parents control over what information is collected from their young children online. This increased scrutiny by lawmakers of the data collection and use practices of child-friendly apps should serve as a reminder for app developers to review their products, and the terms of their agreements with the advertising companies they work with, for compliance with COPPA.

Effective January 1, 2020, California will require manufacturers of “connected devices” to equip those devices with reasonable security features. An example of a reasonable security feature (provided in the bill) would be to assign each device a unique password or to prompt the user to generate a password on setup.

This new law follows a trend that has been gathering steam since 2015, when the FTC provided security guidance to Internet of Things device manufacturers. Just a year later, the Mirai botnet used a DDos attack to take down a number of popular web services, in one of the first major Internet of Things attacks. DDos attacks leverage the internet connections (bandwidth) of large numbers of unsuspecting persons. First, the bad-actor infects the person’s device with malware. Then these devices can be remotely-forced to connect simultaneously to various targets (think Netflix), overwhelming their ability to communicate and shutting down the service. These types of large-scale attacks are especially dangerous in the Internet of Things context, where otherwise innocuous devices such as light-fixtures, DVRs, toasters, pet-feeders, and countless others begin to come online.

While this new bill asks very little of manufacturers, it is a crucial first step that will force manufacturers of internet-connected devices to put in place at least some common-sense security features.

Our take

This new bill requires very little of manufacturers and provides very little in terms of security for consumers. To address Internet of Things security, both regulators and companies need to provide platforms and standards that are easy to integrate, update, and adopt.

Just last month, the National Institute of Standards and Technology (“NIST”), in concert with the National Cybersecurity Center of Excellence (“NCCoE”), jointly published a behemoth guide to securing Electronic Health Records (“EHR”) on mobile devices.

The guide is a reaction to the growing number of issues with EHR in the mobile application context, as healthcare organizations often have poor EHR integration with their mobile apps. Mobile devices have so many obvious benefits from patient communication to care coordination that organizations are going with the implement first, secure later approach, creating major headaches down the road when the inevitable security incident occurs. In their guide, NIST and NCCoE provide a full analysis of provider side access risks where the provider adds patient information into an EHR system through a mobile device and that same EHR data is accessed elsewhere by another provider via a separate mobile device.

The guide provides a roadmap for healthcare organizations that:

  • maps security characteristics to standards and best practices from NIST and other standards organizations, and to the HIPAA Security Rule
  • provides a detailed architecture and capabilities that address security controls
  • facilitates ease of use through automated configuration of security controls
  • addresses the need for different types of implementation, whether in-house or outsourced
  • provides a how-to for implementers and security engineers seeking to re-create or reference design in whole or in part

We recommend reviewing the guide during the planning phase of any EHR-related mobile application implementation. For a quick overview of the guide, see the one page fact sheet here.

Our take

The guide provides a timely and valuable starting point for CIOs and Privacy Officers that are considering a mobile app implementation. At a high level, §8’s Risk Questionnaire (page 216) provides a great resource for those organizations looking to understand the types of questions they need to ask when selecting a cloud-based EHR vendor. The tables that follow these questionnaires will help an engaged leader to understand the universe and severity of the risks that come with the move to mobile.

On August 30, 2018, in honor of the 22nd anniversary of the introduction of HIPAA, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) and the Office of the National Coordinator for Health Information Technology (“ONC”) released a blog post entitled “HIPAA & Health Information Portability: A Foundation for Interoperability.” This blog post outlines the initiatives HHS and its components, including the Centers for Medicare & Medicaid Services (“CMS”) and the National Institutes for Health (“NIH”), have recently taken to improve individual access to health information and to promote the secure portability of health information. For example, OCR and ONC have initiated a campaign to encourage individuals to “get, check, and use” their health information and to take advantage of their right to access their health information as a means of taking greater control over their health care decisions. These resources for individuals are available here. Moreover, OCR and ONC have issued guidance and training resources about the HIPAA right of access for health care providers. The training module for health care providers about patients’ right of access is available here.

Additionally, CMS has asked for comment on whether CMS should make interoperability a requirement for providers that participate in the Medicare program. See “Speech: Medicare Remarks by CMS Administrator Seema Verma at the Commonwealth Club of California” available here. Furthermore, NIH has established a research program that will require the portability of health information.

The HHS blog post is available here.

Our take

This guidance suggests that HHS is cracking down on violations of the HIPAA individual right of access. Therefore, health care organizations must be cognizant of the importance of providing individuals with access to their health information within 30 days (and no later than 60 days) of the individual’s request.