Thinking about or using mobile devices and applications in your heath care, health plan, or related operations or struggling to meet the demands of employees, patients, plan members or others to allow use of these tools? Be sure that you’ve taken appropriate steps to design, implement and manage legal responsibilities and risks associated with the development and use of these tools.
While the popularity, accessibility and cost-effectiveness of mobile devices and applications provides a strong incentive for health plans, health care providers, their business associates, workforce members and customers to use mobile devices and applications, the use of these technologies and applications to collect, access, or use personal health care, financial, or other sensitive information presents special challenges and risks. Unfortunately, as the use of these tools proliferates, federal officials are increasingly concerned that the data security protections afforded by many of the devices and applications in use on these highly popular smart phone, tablet and other mobile devices and applications is highly lacking. See FTC Settlement With Mobile Device & App Developer Shows Developers & Businesses Need To Manage Mobile App & Data Security.
As federal regulators and law enforcement responds to growing concerns about cyber security and other risks, heath care, health plan and other businesses, their employees, customers, and other business partners jumping on the mobile device and application bandwagon, health, application bandwagon, and the device and application developers developing and offering these tools must take appropriate steps to manage the personal health, financial, and other sensitive information and data that these tools use, create, access or disclose.
The Health Insurance Portability & Accountability Act (HIPAA) generally requires that health care providers, health plans, health care clearinghouses and their businesses associates safeguard personal health care information or “PHI” and restrict its use, access and disclosure in accordance with the extensive and highly detailed requirements of the Privacy, Security and Breach Notification Regulations of the Department of Health & Human Services Office of Civil Rights (OCR).
OCR’s collection of several multi-million dollar settlements as well as its statements in its recent restated HIPAA regulations and other OCR guidance make clear that OCR views HIPAA as imposing significant responsibilities upon covered entities and their business associates to safeguard and restrict access to PHI on mobile devices and applications. OCR’s Long-Anticipated Omnibus HIPAA Privacy, Security, Breach Notification & Enforcement Rule Tightens Privacy Requirements, Require Action; Breaches resulting from the loss or theft of unencrypted ePHI on mobile or other computer devices or systems has been a common basis of investigation and sanctions since that time, particularly since the Breach Notification rules took effect. OCR Pops Idaho Hospice In 1st HIPAA Breach Settlement Affecting < 500 Patients; Providence To Pay $100000 & Implement Other Safeguards; OCR Hits Alaska Medicaid For $1.7M+ For HIPAA Security Breach; OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks; $1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report; HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website. These actions and statements of OCR provide a clear warning to HIPAA-covered entities and their business associates to expect significant consequences for failing to properly encrypt and safeguard ePHI used, accessed or disclosed on mobile devices and applications.
Of course, HIPAA shouldn’t be the only standard considered when health care providers, health plans or their business partners and vendors design and use mobile applications. In addition to HIPAA’s requirements on PHI, health care providers, health plans, health care clearinghouses, and their business partners also generally can expect that mobile devices and applications used in connection with their operations by patients, customers, employees or others also may use access, collect or disclose credit card, financial and a broad range of other sensitive information required to be protected under federal laws like the Fair & Accurate Credit Transactions Act (FACTA) or other Federal Trade Commission (FTC) Rules, state data security, data breach, identity theft or other privacy rules or both. Depending on the nature of the data and the circumstances of the unanticipated use or disclosure, invasion of privacy or other common or statutory laws also may come into play.
With the use of these applications by consumers and business proliferates, Congress, OCR, the FTC, state regulators and others are upping the responsibilities and the liability of businesses that fail to appropriately consider and implement security in their mobile devices and applications. Following on OCR’s restatement of its HIPAA regulations, the Obama Administration’s announcement of new cyber security initiatives, and a plethora of other federal and state regulatory and enforcement actions against businesses for data security missteps, the FTC recently launched a campaign to ensure that companies secure the software and devices mobile device and application providers provide consumers.
Earlier this month, the FTC introduced Mobile App Developers: Start with Security, a new business guide that encourages app developers to aim for reasonable data security.
On June 4, 2013, the FTC also plans to host a public forum on malware and other mobile security threats in order to examine the security of existing and developing mobile technologies and the roles that various members of the mobile ecosystem can play in protecting consumers.
Along side this educational outreach, the FTC also is moving to punish businesses that fail to act responsibly to protect sensitive data. This trend is illustrated by the FTC’s announcement this week of its first settlement with a mobile device manufacturer.
FTC Charges Against HTC America
This week, the FTC announced that mobile device giant HTC American, Inc. will to settle FTC charges that the company failed to take reasonable steps to secure the software it developed for its smart phones and tablet computers and introduced security flaws that placed sensitive information about millions of consumers at risk.
A leading mobile device manufacturer in the United States, HTC America develops and manufactures mobile devices based on the Android, Windows Mobile, and Windows Phone operating systems. HTC America has customized the software on these devices in order to differentiate itself from competitors and to comply with the requirements of mobile network operators.
In its first-ever complaint against a mobile device or application developer, the FTC charged HTC America failed to incorporate and administer appropriate safeguards for personal financial and other sensitive data accessed and used in these applications when designing or customizing the software on its mobile devices. Among other things, the complaint alleged that HTC America failed to provide its engineering staff with adequate security training, failed to review or test the software on its mobile devices for potential security vulnerabilities, failed to follow well-known and commonly accepted secure coding practices, and failed to establish a process for receiving and addressing vulnerability reports from third parties.
To illustrate the consequences of these alleged failures, the FTC’s complaint details several vulnerabilities found on HTC America’s devices, including the insecure implementation of two logging applications – Carrier IQ and HTC Loggers – as well as programming flaws that would allow third-party applications to bypass Android’s permission-based security model.
Due to these vulnerabilities, the FTC charged, millions of HTC devices compromised sensitive device functionality, potentially permitting malicious applications to send text messages, record audio, and even install additional malware onto a consumer’s device, all without the user’s knowledge or consent. The FTC alleged that malware placed on consumers’ devices without their permission could be used to record and transmit information entered into or stored on the device, including, for example, financial account numbers and related access codes or medical information such as text messages received from healthcare providers and calendar entries about doctor’s appointments. In addition, malicious applications could exploit the vulnerabilities on HTC devices to gain unauthorized access to a variety of other sensitive information, such as the user’s geolocation information and the contents of the user’s text messages.
Moreover, the FTC complaint alleged that the user manuals for HTC Android-based devices contained deceptive representations, and that the user interface for the company’s Tell HTC application was also deceptive. In both cases, the security vulnerabilities in HTC Android-based devices undermined consent mechanisms that would have otherwise prevented unauthorized access or transmission of sensitive information.
HTC America Settlement
The settlement not only requires the establishment of a comprehensive security program, but also prohibits HTC America from making any false or misleading statements about the security and privacy of consumers’ data on HTC devices. Under the settlement agreement, HTC American must:
- Fix vulnerabilities found in millions of HTC devices;
- Establish a comprehensive security program designed to address security risks during the development of HTC devices; and
- Undergo independent security assessments every other year for the next 20 years.
HTC America and its network operator partners are also in the process of deploying the security patches required by the settlement to consumers’ devices. Many consumers have already received the required security updates. The FTC is encouraging consumers using HTC America applications to apply the updates as soon as possible.
The FTC Commission vote to accept the consent agreement package containing the proposed consent order for public comment was 3-0-2, with Chairman Jon Leibowitz not participating and Commissioner Maureen Ohlhausen recused. The FTC will publish a description of the consent agreement package in the Federal Register shortly.
In accordance with FTC procedures, the settlement agreement will be subject to public comment through March 22, after which the Commission will decide whether to make the proposed consent order final. Interested parties can submit comments electronically or in paper form using instructions in the “Invitation To Comment” part of the “Supplementary Information” section. Comments in paper form should be mailed or delivered to: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue, N.W., Washington, DC 20580. The FTC is requesting that any comment filed in paper form near the end of the public comment period be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions.
Act To Manage Mobile Application Device & Security
Given the expanding awareness, expectations and enforcement of OCR, FTC and others, health care, health plan and other industry participants deciding whether and when to use, or allow others to use mobile devices or applications to access data or carry out other activities and the mobile device or other technology developers and providers offering products or services to these organizations must get serious about security.
These and other related activities send a clear message that health care, health insurance mobile device and application users and developers must incorporate and administer appropriate processes and safeguards to protect PHI, personal financial and other sensitive data. In response to these developments, industry mobile device and application developers and the health care, health insurance and other businesses must consider carefully before deploying or allowing others to deploy or use these tools in relation to data within their operations or systems. Before and when using or permitting customers, business partners, employees or others to use tools, these organizations must ensure the adequacy of the design and security safeguards for their devices, software and applications, as well as their disclaimers and associated consumer disclosures and consents. Because of the special legal and operational expectations for these organizations, health care, health insurance and other industry provides must resist pressure to allow the use of these tools unless and until they can verify that these legal and operational requisites are fulfilled.
For More Information Or Assistance
If you need assistance reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.
A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.
Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.
If you found this article of interest, you also may be interested in other recent Solutions Law Press, Inc. articles by Ms. Stamer including:
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- OCR Pops Idaho Hospice In 1st HIPAA Breach Settlement Affecting < 500 Patients
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