The California Consumer Privacy Act (CCPA) is a state statute intended to enhance consumer protection and data privacy rights of the residents of California, United States. It is widely considered one of the most sweeping consumer privacy laws, giving Californians the strongest data privacy rights in the U.S.
The focus of this article is CCPA as it applies to Healthcare. Let’s take a quick look at what CCPA is and then move onto its relevance for Healthcare entities. CCPA is applicable to any for-profit organization – regardless of whether it physically operates out of California – that interacts with, does business with and/or collects, processes or monetizes personal information of California residents AND meets at least one of these criteria: has annual gross revenue in excess of $25 million USD; collects or transacts with the personal information of 50,000 or more California consumers, households, or devices; earns 50% or more of its annual revenue by monetizing such data. CCPA also empowers California consumers with the rights to complete ownership; control; and security of their personal information and imposes new stringent responsibilities on businesses to enable these rights for their consumers.
Impact on Healthcare Companies
Companies directly or indirectly involved in the healthcare sector and dealing with medical information are regulated by the Confidentiality of Medical Information Act (CMIA) and the Health Insurance Portability and Accountability Act (HIPAA). CCPA does not supersede these laws & does not apply to ‘Medical Information (MI)’ as defined by CMIA, or to ‘Protected Health Information (PHI)’ as defined by HIPAA. CCPA also excludes de-identified data and information collected by federally-funded clinical trials, since such research studies are regulated by the ‘Common Rule’.
The focus of the CCPA is ‘Personal Information (PI)’ which means information that “identifies, relates to, describes, is capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular consumer or household.” PI refers to data including but not limited to personal identifiers such as name, address, phone numbers, email ids, social security number; personal details relating to education, employment, family, finances; biometric information, geolocation, consumer activity like purchase history, product preferences; internet activity.
So, if CCPA only regulates personal information, are healthcare companies that are already in compliance with CMIA and HIPAA safe? Is there anything else they need to do?
Well, there is a lot that needs to be done! This only implies that such companies should continue to comply with those rules when handling Medical Information as defined by the CMIA, or Protected Health Information, as defined by HIPAA. They will still need to adhere to CCPA regulations for personal data that is outside of MI and PHI. This will include employee personal information routinely obtained and processed by the company’s HR; those collected from websites, health apps, health devices, events; clinical studies that are not funded by the federal government; information of a CCPA-covered entity that is handled by a non-profit affiliate, to give a few examples.
There are several possibilities – some not so apparent – even in healthcare entities, for personal data collection and handling that would fall under the purview of CCPA. They need to take stock of the different avenues through which they might be obtaining/handling such data and prioritize CCPA compliance. Else, with the stringent CCPA regulations, they could quickly find themselves embroiled in class action lawsuits (which by the way, do not require proof of damage to the plaintiff) in case of data breaches, or statutory penalties of up to $7500 for each violation.
The good news is that since CCPA carves out a significant chunk of data that healthcare companies/those involved in healthcare-related functions collect and process, entities that are already complying with HIPAA and CMIA are well into the CCPA compliance journey. A peek into the kind of data CMIA & HIPAA regulate will help gauge what other data needs to be taken care of.
CMIA protects the confidentiality of Medical Information (MI) which is “individually identifiable information, in electronic or physical form, in possession of or derived from a provider of health care, health care service plan, pharmaceutical company, or contractor regarding a patient’s medical history, mental or physical condition, or treatment.”
HIPAA regulates how healthcare providers, health plans, and healthcare clearinghouses, referred to as ‘covered entities’ can use and disclose Protected Health Information (PHI), and requires these entities to enable protection of data privacy. PHI refers to individually identifiable medical information such as medical records, medical bills, lab tests, scans and the like. This also covers PHI in electronic form(ePHI). The privacy and security rule of HIPAA is also applicable to ‘business associates’ who provide services to the ‘covered entities’ that involve the use or disclosure of PHI.
Two other types of data that are CCPA exempt are Research Data & De-Identified Data. As mentioned above, the ‘Common Rule’ applies only to federally-funded research studies, and the CCPA does not provide much clarity on exemption status for data from clinical trials that are not federally-funded.
And, although the CCPA does not apply to de-identified data, the definitions of de-identified data of HIPAA and CCPA slightly differ which makes it quite likely that de-identified data by HIPAA standards may not qualify under CCPA standards and therefore would not be exempt from CCPA regulations.
Compliance Approach
Taking measures to ensure compliance with regulations is cumbersome and labour-intensive, especially with the constantly evolving regulatory environment. Using this opportunity for a proactive, well-thought-out approach for comprehensive enterprise-wide data security and governance will be strategically wise since it will minimize the need for policy and process rehaul with each new regulation.
The most crucial step is a thorough assessment of the following:
- Policies, procedures, workflows, entities relating to/involved in data collection, sharing and processing, in order to arrive at clear enterprise-wide data mapping; to determine what data, data activities, data policies would fall under the scope of CCPA; and to identify gaps and decide on prioritized action items for compliance.
- Business processes, contracts, terms of agreement with affiliates, partners and third-party entities the company does business with, to understand CCPA applicability. In some cases, HIPAA and CMIA may be applicable to only the healthcare-related business units, subjecting other business units to CCPA compliance.
- Current data handling methods, not just its privacy & security. CCPA dictates that companies need to have mechanisms put in place to cater to CCPA consumer right to request all information relating to the personal data collected about them, right to opt-out of sale of their data, right to have their data deleted by the organization (which will extend to 3rd parties doing business with this organization as well).
Consumer Consent Management
With CCPA giving full ownership and control of personal data back to its owners, consent management mechanisms become the pivot of a successful compliance strategy. An effective mechanism will ensure proper administration and enforcement of consumer authorizations.
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