In the U.S., we do not, today, have a national privacy law. Pressure from the EU and California are driving an extensive national debate on this topic. But how is this pressure impacting the health care industry, both today and going forward? Part one of this two-part series explored how we got to where we are today with health care privacy. This second installment assesses options for moving forward to address emerging gaps and an evolving health care industry. Why? Because the substantial history behind the Health Insurance Portability and Accountability Act experience to date also provides meaningful insight into how a future privacy law could work.
Health care in the national privacy law: Today's debate
While the Health Insurance Portability and Accountability Act creates the current baseline for privacy regulation of health information, how else can the privacy of health care information be addressed? Other regimes have chosen different approaches to health care privacy.
The EU General Data Protection Regulation takes a very different approach than HIPAA. Under the GDPR, health information is treated as sensitive data, but there are no specific requirements for the health care industry per se. The GDPR is, therefore, both broader and narrower than HIPAA in its approach. It applies to more kinds of entities that have or use health information, but applies to less information than if that information were held in the U.S. by a covered entity (for example, a name or Social Security number held by a U.S. hospital is protected by HIPAA, while such information would not be health information under the GDPR). There is additional consideration in the GDPR of the health care industry on its own.
California's Confidentiality of Medical Information Act
Some states have their own laws that mirror HIPAA to some extent. (Technically, HIPAA sets a federal floor for privacy protection. It preempts weaker state laws but permits “more stringent” laws that provide greater privacy protections.) California, for example, has the Confidentiality of Medical Information Act. This is a freestanding law — different from the CCPA — that is parallel to HIPAA; it clearly includes many HIPAA-covered entities and business associates, but also includes additional entities that are not subject to HIPAA, primarily entities providing mobile apps or other health technology directly to consumers. It is extremely challenging, to say the least, to evaluate the differences between HIPAA and CMIA for HIPAA-covered entities (and very difficult to apply the law to other kinds of entities that appear to be subject to it).
California Consumer Privacy Act
Then, since California is not confusing enough for health care, we now superimpose the California Consumer Privacy Act on the existing structure. As a general matter, CCPA exempts entities covered by HIPAA. It exempts covered entities for any HIPAA-covered data and business associates for their HIPAA activities. Intriguingly, it also exempts entities covered by the CMIA. The CCPA does seem to cover certain medical information that is held by entities that are not subject to HIPAA or the CMIA. Presumably, the collective approach in California covers all health care information in some way (with the potential exception of certain employer-collected health information not subject to HIPAA). The CCPA, however, is emphasizing the challenges for an industry that now regularly crosses the lines for these different laws.
Federal concepts so far
At the federal level, we are starting to see a variety of approaches to the overall question of national privacy legislation. While health care has not recently been a focus of this debate, each approach has its own perspective on health care and health information, along with its own strengths and weaknesses.
The Protecting Personal Health Data Act, proposed by Sen. Amy Klobuchar, D-Minn., is the only current legislative proposal that focuses on the issue of “non-HIPAA health data.” It creates a focused solution to the “scope” problems left by HIPAA’s tortured legislative history but only takes a “first step” approach to a solution by requiring a task force and then regulations “to help strengthen privacy and security protections for consumers’ personal health data … collected ... by consumer devices.” It targets this current gap but would not create a uniform set of rules across the industry, as we would still have different rules for HIPAA and non-HIPAA data.
Other approaches are more general and take varying approaches to how a new law would intersect with HIPAA. Sen. Ron Wyden's, D-Ore., Consumer Data Protection Act is mainly focused on expanding and increasing Federal Trade Commission authority without addressing health data directly. Another approach, Sen. Brian Schatz's, D-Hawaii, Data Care Act of 2018, defines “sensitive data” to include health care data. Unlike other proposals, the obligations seem to be superimposed on top of HIPAA (similar to the approach of the Sen. Ed Markey, D-Mass., privacy proposal, the Privacy Bill of Rights Act).
Sen. Marco Rubio’s, R-Fla., proposed "American Data Dissemination Act" includes medical history and biometric as categories of data subject to the law but not health data overall. It generally exempts entities subject to HIPAA and preempts state law. In the House of Representatives, Rep.Suzan DelBene, D-Wash., has introduced “The Information Transparency & Personal Data Control Act.” This proposal creates a wide range of obligations related to “sensitive personal information,” including health information, but does not otherwise address the health care industry per se. These provisions appear to be imposed on top of HIPAA, and there is an explicit carve-out from the preemption provision for state laws that are more stringent than HIPAA.
Where are we now?
We can expect significant debate over the next few years on the future of a federal privacy law. While it might be possible for a health care “fix” to move separately, that seems unlikely at this point.
In thinking about the “gaps” in the current HIPAA structure, there are several options. Moving from “most limited” to “broadest” in application, we could see specific proposals approaching this issue in the following ways:
- A specific set of principles applicable only to “non-HIPAA health care data” (with an obvious ambiguity about what “health care data” would mean).
- A set of principles (through an amendment to the scope of HIPAA or some new law) that would apply to all health care data.
- A broader general privacy law that would apply to all personal data (with or without a carve-out for data currently covered by the HIPAA rules), with recognition that it is increasingly difficult to identify “health care information.”
In parallel consideration, a national privacy law could:
- Exempt the health care industry to the extent regulated by HIPAA.
- Include new provisions that apply to HIPAA covered entities, in addition to the existing HIPAA provisions.
- Replace HIPAA with a new structure covering all health care information.
At a minimum, we can expect that any new national privacy law would “cover” “non-HIPAA health care data” (and entities). But, unless a broader approach to health information is taken, that would continue the status quo of different standards depending on who is holding the health information.
Despite the importance of the health care industry, HIPAA and health information to the overall debate about individual privacy, health care has not been a leading factor in the current national privacy legislative debate. This is unfortunate and can lead to problems for both the health care industry and a variety of other stakeholders interested in health care data and the privacy of this data. The HIPAA rules — because of their detail and our broad experience with them over the past 15 years — can provide some useful experience in evaluating the national debate (particularly in HIPAA’s approach to consent and the use and disclosure of covered information).
In general, most relevant stakeholders are comfortable with the HIPAA approach and overall impact of the rules on the operation of the health care industry and the protection of patient data. Despite this comfort, the health care industry and these other stakeholders (including government, employers, researchers, patients and general consumers) need to consider what the next phase of privacy protection for health information should be. The current status quo — where the protection of health information depends dramatically on who holds the information — likely may persist in a national privacy law setting. That has important implications for consumers and for the health care industry. These differing standards create confusion and complexity that easily could be reduced through a common standard.
The health care industry, those in Congress and other relevant stakeholders should be evaluating whether a common standard, even if different from HIPAA, would be better for the industry and for consumers.
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