On 9 March, the Council of the EU issued a partial general approach on a key chapter of the EU Data Protection Regulation which has implications for the regulation of health data. The Council’s stance has been welcomed by a number of healthcare commentators as it promotes a more flexible approach to the use of health data and accords with the tenor of the revised version of the draft Regulation that emerged from the Council in December last year.
Federal health IT leaders emphasized interoperability and computable privacy during the two-day Annual Meeting of the U.S. Office of the National Coordinator for Health Information Technology, which took place on February 2 and 3. Over 1,200 participants representing viewpoints across the healthcare spectrum attended the meeting in Washington, D.C. The meeting built on momentum from last week’s release of ONC’s draft Nationwide Interoperability Roadmap, as well as several high-profile announcements reinforcing the Obama Administration’s commitment to interoperability and privacy.
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.”
Government officials emphasized the importance of risk analysis and risk management in safeguarding PHI at the Seventh Annual “Safeguarding Health Information: Building Assurance Through HIPAA Security” conference held from September 23–24, 2014, and co-hosted by the National Institute of Standards and Technology and the Department of Health and Human Services, Office for Civil Rights. The conference’s themes—which include risk analysis and risk management, information sharing, and upcoming OCR enforcement efforts—highlighted how HIPAA regulated entities should approach cybersecurity considerations and compliance with the HIPAA Security Rule.
The 2009 HITECH Act mandated that the U.S. Department of Health and Human Services Office for Civil Rights conduct periodic audits of covered entities and business associates for compliance with HIPAA privacy and security requirements. In 2012, OCR conducted a pilot audit program involving 115 covered entities. In February 2014, the agency issued a notice in the Federal Register announcing its plan to survey up to 1,200 covered entities and business associates to select organizations for the next round of HIPAA audits.
On August 27, 2014, the National Institutes of Health issued a new Genomic Data Sharing Policy, which replaces the current genome-wide association study data policy that was instituted in 2007. The GDS Policy applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of that data for subsequent research. As discussed in this post, the Policy promotes the use of broad informed consent for future study and sharing.
In a ruling that was welcome news to health care providers, insurers, and others that maintain medical information of California residents, the California Court of Appeals recently held that the mere possession of medical information by an unauthorized person, without actual viewing of the information, is not sufficient to establish a breach of confidentiality under the California Confidentiality of Medical Information Act , Cal. Civ. Code §§ 56 et seq.
On May 7, 2014, the Federal Trade Commission (FTC) held a seminar on Consumer Generated and Controlled Health Data (CGHD) that included participants from government, industry, and advocacy organizations. The seminar—which consisted of opening remarks by FTC Commissioner Julie Brill, brief presentations by FTC representatives on health information data flows and sharing of CGHD with third parties, and a panel discussion moderated by FTC attorneys Kristen Anderson and Cora Han—examined the potential benefits and risks of CGHD.
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.
The U.S. Department of Health and Human Services sent a strong message to local governments last week when it reached a settlement with Skagit County, Washington over alleged violations of the Health Insurance Portability and Accountability Act. This is the first time that HHS has settled charges against a local—and not state level—government entity for HIPAA violations.
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 February 18, Puerto Rican insurer Triple S Salud revealed that it will face a $6.8 million fine for violating the Health Insurance Portability and Accountability Act. According to an 8-K filing submitted to the Securities and Exchange Commission, the Puerto Rico Health Insurance Administration notified Triple S on February 11, 2014 regarding its plans to sanction the insurer for HIPAA violations resulting from a 2013 breach of protected health information. The Health Insurance Administration also plans to impose administrative sanctions on the insurer, including the suspension of new enrollments into one of its plans and the obligation to notify affected individuals of their right to disenroll.
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.
LabMD recently announced its plans to wind down operations, citing its ongoing legal battle with the Federal Trade Commission over the company’s data security practices as a major cause. In a letter dated January 6, LabMD president Michael Daugherty informed the company’s customers and workforce that the medical testing laboratory would no longer be accepting new specimens after January 11 and that the company’s phones and internet access would be discontinued shortly thereafter. Daugherty’s letter blamed the FTC’s “debilitating investigation and litigation” as a major source of the company’s decision to wind down operations.
Last week, California Attorney General Kamala Harris filed suit against Kaiser Foundation Health Plan, Inc. (“Kaiser”) in relation to a 2011 data security breach. The AG’s complaint alleges that even though Kaiser provided notice of the breach to affected individuals, it took too long to issue the required notifications.
Last week the Office of the National Coordinator’s Health IT Policy Committee approved recommendations from its Privacy and Security Tiger Team workgroup to scale back HHS’s proposed accounting of disclosures regulations. The Tiger Team developed its recommendations after months of work, including a September 30 virtual hearing in which the Tiger Team heard testimony from providers, payers, business associates, patient advocates, and other stakeholders.
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 August 28, the Federal Trade Commission (FTC) filed an administrative complaint against medical testing laboratory LabMD based on allegations that the company engaged in “unfair acts or practices” by failing to employ “reasonable and appropriate measures to prevent unauthorized access to personal information.” The FTC’s action in this case stems from an incident in which a file containing personal information on approximately 9,300 individuals allegedly was shared on a peer-to-peer (P2P) network from a company computer with P2P file-sharing software installed. The complaint follows other recent FTC actions in which the agency has relied on its Section 5 authority under the FTC Act to claim that companies’ exposure of data to P2P networks constituted an unlawful, unfair data security practice. The FTC’s action against LabMD makes clear that institutions governed by the Health Insurance Portability and Accountability Act (HIPAA) must also be mindful of the FTC’s increasing enforcement activity related to security controls, including actions against healthcare providers.
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.
In a recently-announced settlement between the Department of Health and Human Services Office for Civil Rights and a New York health plan, the health plan agreed to pay $1.2 million for the breach of electronic patient records stored in the internal memory of digital photocopiers leased and improperly disposed by the plan.
A February 4, 2013 article published by the specialized healthcare news site “Actusoins” revealed data breaches at several French hospitals and clinics, demonstrating that such incidents can occur even in a highly-regulated jurisdiction. The journalist was researching another article, and entered the name of a physician into Google. The journalist was astonished to find at […]
In the most significant change to HIPAA since the law was enacted, the Department of Health and Human Services issued an omnibus HIPAA regulation, which will require substantial operational changes for HIPAA covered entities and their business associates. Ten important changes are: Changes to the data breach rule will make more incidents reportable. Business associates are […]
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 […]
Hogan Lovells partner Marcy Wilder will speak on “Health Policy & Regulatory Environments: A Mobile Perspective” at the 2012 mHealth Summit on December 4. The panel discussion will cover major policies impacting the current and future use of mobile devices in America, specifically addressing the role of mobile devices in accountable care organizations, HIPAA compliance, […]