After a year-long investigation into mobile health apps claiming to be able to measure vital signs or health indicators through smartphone sensors, the New York Attorney General settled claims against three developers alleged to have engaged in “misleading” marketing claims and “irresponsible” privacy practices. Mobile health apps Cardiio and Runtastic claimed that their apps effectively and accurately measured heart rate after vigorous exercise using only a smartphone camera and sensors. The third, Matis, claimed that its app transformed a smartphone into a fetal heart monitor. Concerned that unregulated apps claiming to measure key vital signs and other health indicators may harm consumers if the apps provide inaccurate or misleading results, NY AG Eric Schneiderman brought enforcement actions against the trio of developers.
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Representatives from government and the private sector discussed the present state of healthcare cybersecurity, and experts discussed practical strategies for implementing the HIPAA Security Rule at the ninth annual “Safeguarding Health Information: Building Assurance through HIPAA Security” conference held from October 19–20, 2016 and co-hosted by the National Institute of Standards and Technology and the Department of Health and Human Services, Office for Civil Rights. Comprehensive, enterprise-wide risk analysis and risk management practices remained points of emphasis throughout the conference. Additional themes, which we outline in this post, also emerged.
Cloud service providers are on notice: you are HIPAA business associates, even if you are unable to access the HIPAA protected information in your cloud. The Department of Health and Human Services Office for Civil Rights released guidance making clear that cloud service providers that create, receive, maintain, or transmit electronic protected health information are covered by HIPAA.
On Wednesday, August 17, 2016, the Future of Privacy Forum released a set of detailed guidelines for the collection and use of consumer-generated wellness data. The document, Best Practices for Consumer Wearables & Wellness Apps & Devices, was drafted by FPF with input from a wide range of stakeholders, including privacy advocates, companies, and regulators. The Best Practices guidelines set forth a Fair Information Practice Principles-based trust framework that builds on existing legal expectations to provide a set of best practices providing appropriate protections given the nature and sensitivity of the data.
The Department of Health and Human Services Office for Civil Rights is taking an aggressive stand on HIPAA enforcement and targeting violations related to security risk assessments and business associate agreements. Three resolution agreements posted in the last month make clear that the agency expects entities subject to HIPAA to take appropriate steps to secure their data, regardless of the size or type of the entity.
The Department of Health and Human Services released guidance on July 11, 2016, intended to help the healthcare industry prepare for and respond to ransomware attacks. Specifically, this guidance clarifies: (1) that a ransomware attack is considered a “security incident” under HIPAA, and (2) that a ransomware attack will typically be considered a “breach” by HHS unless entities are able to demonstrate that there is a “low probability of compromise.” The guidance also clarifies that covered entities must implement the same risk assessment processes as they would with other types of cyber threats, including malware. At a time when ransomware attacks are on the rise, this guidance heightens the potential regulatory enforcement consequences of these events.
The FTC released this week a web-based tool to assist mobile app developers in determining which federal privacy laws apply to their mobile health applications. The tool asks developers a series of ten targeted questions that help a user determine whether HIPAA, FTC, and/or FDA rules and regulations might apply.
Hogan Lovells hosted the second annual Health Privacy Law Forum for health privacy professionals yesterday. Participants spoke with Deven McGraw, Deputy Director of Health Information Privacy at the U.S. Department of Health and Human Services Office for Civil Rights , and former Federal Trade Commissioner Julie Brill, now a partner at Hogan Lovells and co-chair of its Privacy and Cybersecurity practice.
The revamped audit protocol for the upcoming HIPAA Phase 2 audits has been released by the US Department of Health and Human Services Office for Civil Rights. The audit protocol, which is posted on the HHS website, includes new requirements added by the 2013 Omnibus Final Rule for HIPAA covered entities and business associates. The Phase 2 audits will be more focused, and the stakes will be higher: the agency has indicated that audits may, in certain circumstances, lead to full compliance reviews—with the potential for fines or settlement agreements related to alleged HIPAA noncompliance. In addition, business associates will be subject to HIPAA audits for the first time.
Last week, the Department of Health and Human Services Office for Civil Rights launched the long-awaited Phase 2 HIPAA Audit Program. Earlier this month, the agency posted two resolution agreements that continue the trend toward big dollar settlement amounts and a focus on security risk assessments and business associate agreements. With Phase 2 HIPAA Audits underway and more full-scale compliance reviews triggered by data breach reports, it is more important than ever to appropriately protect health information.
The US government has been increasingly active in cybersecurity legislation and enforcement. Congress recently passed the Cybersecurity Act of 2015, which has spurred renewed attention to cybersecurity requirements and cyber threat information sharing. The US government continues to draw attention to how organizations can align their cybersecurity programs with the NIST Cybersecurity Framework. Moreover, a number of federal agencies including the Consumer Financial Protection Bureau, Federal Trade Commission, and Federal Communications Commission have all issued settlements relating to cybersecurity enforcement actions in recent months. In the health sector, the US Department of Health and Human Services has been increasingly focused on cybersecurity, primarily through its HIPAA enforcement activities. Against that backdrop, three recent developments demonstrate the ways in which HHS and the health sector are expanding their cybersecurity focus beyond HIPAA Security Rule compliance.
Following the launch of its mHealth Developer Portal last October, the HHS Office for Civil Rights has released guidance clarifying how HIPAA applies to mobile health apps. Ensuring that developers understand their legal obligations is critical to protecting consumer privacy and security, especially now that there are more than 165,000 health apps available in the iTunes and Android app stores. A more clear understanding of how the rules apply can also help bring down barriers to innovation.
Last month, tucked into a 2,000-page spending bill, the Cybersecurity Information Sharing Act of 2015 (CISA) was enacted into law. Years in the making, CISA is intended to incentivize organizations to share cyber threat indicators with the federal government and to promote the dissemination of this information to organizations facing similar threats. The spending bill included a number of other cybersecurity provisions covering topics ranging from federal preparedness to foreign policy strategy. Most notably, the bill directs the Department of Health and Human Services to develop cybersecurity best practices for organizations in the healthcare industry. The bill also directs federal agencies to create new plans to fortify federal information systems and identify cyber-related gaps in the federal workforce.
On December 2, the Department of Health and Human Services, Office for Civil Rights announced a $150,000 settlement with Anchorage Community Mental Health Services, Inc. for alleged violations of the HIPAA Security Rule. The announcement followed an OCR investigation into a breach of unsecured electronic protected health information affecting 2,743 individuals. OCR highlighted three Security Rule violations in its resolution agreement: (1) failure to conduct an accurate and thorough risk analysis; (2) failure to implement security policies and procedures; and (3) failure to have reasonable firewalls in place, as well as supported and patched IT resources. In a press release regarding the settlement, OCR Director Jocelyn Samuels noted that “successful HIPAA compliance . . . . includes reviewing systems for unpatched vulnerabilities and unsupported software that can leave patient information susceptible to malware and other risks.”
The medical internet of things is coming. That was the common recognition of participants at a two-day public workshop on “Collaborative Approaches for Medical Device and Healthcare Cybersecurity” co-sponsored by the Food and Drug Administration, Department of Health and Human Services, and the Department of Homeland Security. The workshop comes during a busy month for medical device cybersecurity, with the FDA issuing final guidance earlier this month and DHS indicating that it is reviewing dozens of potential cybersecurity vulnerabilities in medical devices.
The U.S. Department of Health and Human Services (HHS) recently released a security risk assessment (SRA) tool as a resource to assist health care providers in complying with the Health Insurance Portability and Accountability Act (HIPAA) Security Rule.
The Security Rule applies to HIPAA “covered entities”—which include health plans, health care clearinghouses, and most health care providers—that handle electronic protected health information (ePHI). The Security Rule also applies to “business associates” that perform functions or services on behalf of covered entities involving ePHI. The Rule requires covered entities and business associates to conduct a risk assessment to identify possible gaps in their information security programs in order to help ensure that patient information is protected against data breaches or other security events.
HHS has issued new guidance addressing when it is appropriate under the HIPAA Privacy Rule for a health care provider to share the protected health information of a patient who is being treated for a mental health condition. The guidance does not impose new obligations, but rather is intended to clarify the application of existing HIPAA requirements to the disclosure of mental health information. Covered entity providers that handle such information may find it helpful to review the guidance to ensure that their practices are consistent with regulatory expectations.
On January 31, the Federal Trade Commission announced a settlement with GMR Transcription Services following the public exposure of thousands of medical transcript files containing personal medical information. According to the FTC complaint, GMR failed to adequately verify that its overseas service provider implemented reasonable and appropriate security measures to protect personal information being transmitted and processed. This settlement, the FTC’s 50th with respect to data security, highlights the need for companies to engage in thorough vendor management and oversight with respect to data security practices.
On September 30, 2013 (11:45am – 5:00pm EDT), the US Health Information Technology Policy Committee’s Privacy and Security “Tiger Team” will convene an online public hearing to discuss how to improve transparency for patients about the uses and disclosures of their identifiable, electronic health information. This may result in recommendations from the Policy Committee to HHS, which is considering how to implement HIPAA requirements relating to an individual’s right to an “accounting” of disclosures of their protected health information made through an electronic health record.
On September 19, the Department of Health and Human Services issued new guidance on the “refill reminder” requirements under HIPAA. The new final HIPAA regulations, most of which go into effect on September 23, 2013, limit the remuneration that a covered entity may receive in exchange for making communications to patients about a drug or biologic currently prescribed to that patient.
The Department of Health and Human Services (HHS) just released the highly anticipated final regulations implementing the privacy and security provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act. The regulations address: Final modifications to the HIPAA Privacy, Security and Enforcement Rules mandated by the HITECH Act; Final rule adopting changes […]
Today the U.S. Department of Health and Human Services (HHS) issued a voluntary privacy notice for Personal Health Records (PHRs) as well as new proposed rules that would expand the rights of patients to access test result reports directly from clinical laboratories covered by HIPAA. Both announcements were part of a HHS Consumer Health IT […]
The U.S. Department Health and Human Services Office of the Inspector General issued two reports yesterday criticizing the Centers for Medicare and Medicaid Services (“CMS”) and the Office of the National Coordinator for Health IT (“ONC”) for doing too little to protect the security of patient health information. The first report, Nationwide Rollup Review of the Centers for Medicare & Medicaid Services HIPAA Oversight, found that CMS oversight and enforcement “were not sufficient to ensure that covered entities, such as hospitals, effectively implemented the Security Rule.”