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California Bill Proposes CCPA Exceptions for HIPAA De-identified Information, Other Health Data

On January 6, 2020, the California State Senate’s Health Committee unanimously approved California AB 713, a bill that would amend the California Consumer Privacy Act (CCPA) to except from CCPA requirements additional categories of health information, including data de-identified in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), medical research data, personal information used for public health and safety activities, and patient information that is maintained by HIPAA business associates in the same manner as HIPAA protected health information (PHI). If enacted, the bill would simplify CCPA compliance strategies for many HIPAA-regulated entities, life sciences companies, research institutions and health data aggregators.

Exemption for HIPAA Business Associates

Presently, the CCPA does not regulate PHI that is collected by either a HIPAA covered entity or business associate.

The CCPA also exempts covered entities to the extent that they maintain patient information in the same manner as PHI subject to HIPAA. The CCPA does not, however, currently include a similar entity-based exemption for business associates.

AB 713 would add an exemption for business associates to the extent that they maintain, use and disclose patient information consistent with HIPAA requirements applicable to PHI. For example, if a business associate maintains consumer-generated health information that is not PHI, but processes the information in accordance with HIPAA requirements for PHI, then the information would not be regulated by the CCPA. While the practical import of the new exemption may be limited because business associates may not want to apply HIPAA requirements to consumer-generated health information, AB 713 offers business associates another potential exception to CCPA requirements for patient information about California consumers.

Exception for De-Identified Health Information

AB 713 would except from CCPA requirements de-identified health information when each of the following three conditions are met:

  • The information is de-identified in accordance with a HIPAA de-identification method (i.e., the safe harbor or expert determination method) at 45 CFR § 164.514(b).
  • The information is derived from PHI or “individually identifiable health information” under HIPAA, “medical information” as defined by the California Confidentiality of Medical Information Act (CMIA), or “identifiable private information” subject to the Common Rule.
  • The business (or its business associate) does not actually, or attempt to, re-identify the information.

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Next Generation of Patient Care: Balancing Digital Engagement with Patient and Consumer Privacy

Jennifer Geetter and Lisa Schmitz Mazur wrote this bylined article on the regulatory implications of technology-supported devices, resources, and solutions that facilitate health patient-provider interaction. “Health industry regulators are struggling with how to apply the existing privacy regulatory regime, and the permitted uses and disclosures for which they provide, in this new world of healthcare innovation,” the authors wrote.

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OCR Transmits Pre-Audit Screening Surveys to Covered Entities for Phase 2 HIPAA Compliance Audits

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently transmitted HIPAA pre-audit screening surveys to covered entities that may be selected for a second phase of HIPAA compliance audits (Phase 2 Audits). OCR is required to conduct compliance audits of covered entities and business associates under the 2009 Health Information Technology for Economic and Clinical Health Act.

Unlike the pilot audits conducted in 2011 and 2012 (Phase 1 Audits), which focused on covered entities, OCR is conducting Phase 2 Audits of both covered entities and business associates. The Phase 2 Audit program will focus on areas of greater risk to the security of protected health information (PHI) and pervasive non-compliance based on OCR’s Phase I Audit findings and observations, rather than a comprehensive review of all of the HIPAA Standards. The Phase 2 Audits are also intended to identify best practices and uncover risks and vulnerabilities that OCR has not identified through other enforcement activities. OCR will use the Phase 2 Audit findings to identify technical assistance that it should develop for covered entities and business associates. In circumstances where an audit reveals a serious compliance concern, OCR may initiate a compliance review of the audited organization that could lead to civil money penalties.

OCR had previously planned to issue the pre-audit screening surveys in the summer of 2014, but postponed their release until it completed its implementation of a new web portal that will be used for the submission of audit-related materials.

We will publish a fuller On the Subject regarding the Phase 2 Audits in the coming days.




National Roadmap for Health Data Sharing: FTC Advocates Preservation of Privacy and Competition

On April 1, 2015, the Office of the National Coordinator for Health Information Technology (ONC), which assists with the coordination of federal policy on data sharing objectives and standards, issued its Shared Nationwide Interoperability Roadmap and requested comments.  The Roadmap seeks to lay out a framework for developing and implementing interoperable health information systems that will allow for the freer flow of health-related data by and among providers and patients.  The use of technology to capture and understand health-related information and the strategic sharing of information between health industry stakeholders and its use is widely recognized as critical to support patient engagement, improve quality outcomes and lower health care costs.

On April 3, 2015, the Federal Trade Commission issued coordinated comments from its Office of Policy Planning, Bureau of Competition, Bureau of Consumer Protection and Bureau of Economics.  The FTC has a broad, dual mission to protect consumers and promote competition, in part, by preventing business practices that are anticompetitive or deceptive or unfair to consumers.  This includes business practices that relate to consumer privacy and data security.  Notably, the FTC’s comments on the Roadmap draw from both its pro-competitive experience and its privacy and security protection perspective, and therefore offer insights into the FTC’s assessment of interoperability from a variety of consumer protection vantage points.

The FTC agreed that ONC’s Roadmap has the potential to benefit both patients and providers by “facilitating innovation and fostering competition in health IT and health care services markets” – lowering health care costs, improving population health management and empowering consumers through easier access to their personal information.  The concepts advanced in the Roadmap, however, if not carefully implemented, can also have a negative effect on competition for health care technology services.  The FTC comments are intended to guide ONC’s implementation with respect to: (1) creating a business and regulatory environment that encourages interoperability, (2) shared governance mechanisms that enable interoperability, and (3) advancing technical standards.

Taking each of these aspects in turn, creating a business and regulatory environment that encourages interoperability is important because, if left unattended, the marketplace may be resistant to interoperability.  For example, health care providers may resist interoperability because it would make switching providers easier and IT vendors may see interoperability as a threat to customer-allegiance.  The FTC suggests that the federal government, as a major payer, work to align economic incentives to create greater demand among providers for interoperability.

With respect to shared governance mechanisms, the FTC notes that coordinated efforts among competitors may have the effect of suppressing competition.  The FTC identifies several examples of anticompetitive conduct in standard setting efforts for ONC’s consideration as it considers how to implement the Roadmap.

Finally, in advancing core technical standards, the FTC advised ONC to consider how standardization could affect competition by (1) limiting competition between technologies, (2) facilitating customer lock-in, (3) reducing competition between standards, and (4) impacting the method for selecting standards.

As part of its mission to protect consumers, the FTC focuses its privacy and security [...]

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Consumer Health Information Update from Both Sides of the Atlantic

As we reported in May 2014, the Federal Trade Commission (FTC) convened stakeholders to explore whether health-related information collected from and about consumers — known as consumer-generated health information (CHI) — through use of the internet and increasingly-popular lifestyle and fitness mobile apps is more sensitive and in need of more privacy-sensitive treatment than other consumer-generated data.

One of the key questions raised during the FTC’s CHI seminar is: “what is consumer health information”?  Information gathered during traditional medical encounters is clearly health-related.  Information gathered from mobile apps designed as sophisticated diagnostic tools also is clearly health-related — and may even be “Protected Health Information,” as defined and regulated by Health Information Portability and Accountability Act (HIPAA), depending on the interplay of the app and the health care provider or payor community.  But, other information, such as diet and exercise, may be viewed by some as wellness or consumer preference data (for example, the types of foods purchased).  Other information (e.g., shopping habits) may not look like health information but, when aggregated with other information generated by and collected from consumers, may become health-related information.  Information, therefore, may be “health information,” and may be more sensitive as such, depending on (i) the individual from whom it is collected, (ii) the context in which it is initially collected; (iii) the other information which it is combined; (iv) the purpose for which the information was initially collected; and (v) the downstream uses of the information.

Notably, the FTC is not the only regulatory body struggling with how to define CHI.  On February 5, 2015, the European Union’s Article 29 Working Party (an EU representative body tasked with advising EU Member States on data protection) published a letter in response to a request from the European Commission to clarify the definitional scope of “data concerning health in relation to lifestyle and wellbeing apps.”

The EU’s efforts to define CHI underscore the importance of understanding CHI.  The EU and the U.S. data privacy and security regimes differ fundamentally in that the EU regime broadly protects personally identifiable information.  The US does not currently provide universal protections for personally identifiable information.  The U.S. approach varies by jurisdiction and type of information and does not uniformly regulate the mobile app industry or the CHI captured by such apps.  These different regulatory regimes make the EU’s struggle to define the precise scope and definition of “lifestyle and wellbeing” data (CHI) and develop best practices going forward all the more striking because, even absent such a definition, the EU privacy regime would offer protections.

The Article 29 Working Party letter acknowledges the European Commission’s work to date, including the European Commission’s “Green Paper on Mobile Health,” which emphasized the need for strong privacy and security protections, transparency – particularly with respect to how CHI interoperates with big data  – and the need for specific legislation on CHI-related  apps or regulatory guidance that will promote “the safety and performance of lifestyle and wellbeing apps.”  But, [...]

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Thinking Outside the HIPAA Box

On Wednesday, May 7, the Federal Trade Commission (FTC) held the third of its Spring Seminars on emerging consumer privacy issues.  This session focused on consumer-generated health information (CHI).  CHI is data generated by consumers’ use of the Internet and mobile apps that relates to an individual’s health.  The “H” in CHI defies easy definition but likely includes, at minimum, data generated from internet or mobile app activity related to seeking information about specific conditions, disease/ medical condition management tools, support and shared experiences through online communities or tools for tracking diet, exercise or other lifestyle data.

In the United States, many consumers (mistakenly) believe that all of their health-related information is protected, at the federal level, by the Health Information Portability and Accountability Act (HIPAA).  HIPAA does offer broad privacy protections to health-related information, but only to identifiable health information received by or on behalf of a “covered entity” or a third party working for a covered entity.  Covered entities are, essentially, health plans and health care providers who engage in reimbursement transactions with health plans (referred to as “Protected Health Information” or “PHI”). When HIPAA was enacted in 1996, PHI was the primary type of health information, but CHI, which is generally not also PHI, has changed that.  As FTC Commissioner Julie Brill noted her in her opening remarks, CHI is “health data stored outside the HIPAA silo.”

Without the limitations imposed by HIPAA, online service providers and mobile apps generally (except where state law requires differently) can treat CHI like other digital non-health data that they collect from consumers.  As a result, the FTC expressed concerned that CHI may be aggregated, shared and linked in ways that consumers did not foresee and may not understand.

The panelists at the FTC discussed the difficulty in defining CHI, and whether and how it is different from other kinds of data collected from consumers.  One panelist noted that whether a consumer considers his or her CHI sensitive is highly individualized.  For example, are the heart rate and exercise data collected by mobile fitness apps sensitive? Would the answer to this question change if these data points were linked with other data points that began to suggest other health or wellness indicators, just as weight?  Would the answer change if that linked data was used to predict socioeconomic status that is often linked to certain health, wellness and lifestyle indicators or used to inform risk rating or direct to consumer targeted advertising?

Panelists also discussed the larger and more general question of how to define privacy in a digital economy and how to balance privacy with the recognized benefits of data aggregation and data sharing.  These questions are compounded by the difficulty of describing data as being anonymized or de-identified – foundational principles in most privacy frameworks – because the quality of being “identifiable” in the digital economy may depend on the proximity of a piece of data to other pieces of data.

Though the “how” and “what” of additional [...]

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