45 CFR 155.260
Privacy and security of personally identifiable information (45 CFR 155.260) — US Department of Health and Human Services (CMS)
Also known as: 45 CFR 155.260, Exchange privacy and security standards, ACA Exchange PII
At a glance
- Status
- In force
- Next deadline
- None announced
- How it is assessed
- Exchanges must keep assessing their own controls, and HHS oversees compliance through audits, investigations and inspections. source
- Authority
- The US Department of Health and Human Services (HHS), through CMS, oversees the Federally-facilitated Exchanges and State Exchanges; State Exchanges oversee the non-Exchange entities bound to their standards. source source
- Enforced by
- Knowing and willful misuse or disclosure of Exchange information carries a civil money penalty per use or disclosure, on top of any other penalties in law. source
- Last change
- None recorded yet
The clause that carries health-insurance Exchange privacy down the contracting chain. An Exchange may only create, collect, use or disclose personally identifiable information to the extent necessary to run its statutory functions, and it must bind every non-Exchange entity it works with — issuers, navigators, agents, contractors — to the same standards by agreement, with monitoring and a written breach duty. Operators read it as the Marketplace counterpart of the HIPAA Security Rule.
Recent changes
No changes recorded yet — we are watching, and nothing has been published.
Key dates
No upcoming datesAmendments
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45 CFR 155.260 (as amended September 2016) AmendmentCurrent text
The civil money penalty in paragraph (g) became "$25,000 as adjusted annually under 45 CFR part 102" as part of HHS's inflation adjustment of civil penalties. source
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Notice of Benefit and Payment Parameters for 2017 Amendment
Technical correction to paragraph (a)(1) so that it cites section 155.300 for the definition of insurance affordability programs. source
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Exchange and Insurance Market Standards for 2015 and Beyond Amendment
Revised paragraph (g) so that the existing civil money penalty of up to $25,000 per person or entity, per use or disclosure, follows the bases and process in the new 45 CFR 155.285. source
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Notice of Benefit and Payment Parameters for 2015 Amendment
Revised paragraphs (a)(1), (a)(2) and (b), adding the process for HHS approval of other uses and disclosures and the contract terms that bind non-Exchange entities. source
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Correction of the Exchange establishment rule Errata
Corrected wording in paragraphs (a)(3) and (d) of section 155.260. source
Show 1 older amendment
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Establishment of Exchanges final rule Major version
Created section 155.260 as part of the rule establishing Exchanges and qualified health plans; effective 29 May 2012. source
Who it applies to
Binds the Exchange itself and, by contract, every non-Exchange entity that handles applicants' personally identifiable information for it.
- Purpose limit
- An Exchange may use or disclose eligibility and enrollment PII only as needed for its functions, or for other functions approved by HHS with the individual's consent. source
- Eight principles
- The Exchange's standards must follow eight principles: individual access, correction, openness, individual choice, collection and use limits, data quality, safeguards and accountability. source
- Non-Exchange entities
- Any person or entity that gains access to PII submitted to an Exchange, or collects it from applicants while performing functions agreed with the Exchange. source
- Contract terms
- Before access, the Exchange must sign an agreement binding the entity to its privacy and security standards, to monitor its controls, report material changes and bind downstream entities. source
- Tax information
- Federal tax return information must be kept confidential and used only in accordance with section 6103 of the Internal Revenue Code. source
- Control catalogue
- CMS describes ARC-AMPE as the next iteration of its Exchange security and privacy standards (citing section 155.260); ACA Administering Entities and select Partner Entities must comply with ARC-AMPE Volume II. source
How compliance is assessed
Exchanges must keep assessing their own controls, and HHS oversees compliance through audits, investigations and inspections.
- Ongoing assessment
- The Exchange must monitor, periodically assess and update its security controls, and must require the same of non-Exchange entities by contract. source
- Written policies
- Privacy policies and procedures must be in writing and available to the Secretary of HHS on request. source
- HHS oversight
- HHS may conduct audits, investigations, inspections and other oversight, and may pursue civil, criminal or administrative proceedings. source
- ARC-AMPE artifacts
- Entities subject to ARC-AMPE Volume II complete artifacts, such as a System Security and Privacy Plan, to document their compliance. source source
Enforcement and penalties
Knowing and willful misuse or disclosure of Exchange information carries a civil money penalty per use or disclosure, on top of any other penalties in law.
- Who can be penalised
- Individuals, corporations, Exchanges, Medicaid and CHIP agencies, agents, brokers, web-brokers, issuers, Navigators, assisters and other third-party contractors. source
- Factors
- HHS may weigh the number and severity of violations and the person's history with the Exchange, among other factors. source
Documents
- Law text 45 CFR 155.260 – Privacy and security of personally identifiable information
- Law text 45 CFR 155.280 – Oversight and monitoring of privacy and security requirements
- Law text 45 CFR 155.285 – Civil penalties for improper use or disclosure of information
- Guidance ARC-AMPE Volume I (Version 1.02, April 2025)
- Template CMS Marketplace regulations and guidance (ARC-AMPE Volume II overlays)
Show 1 more document
Verified against official sources on 18 October 2026. We monitor the official sources for this framework. Watching since 20 September 2026. Subscribe to 45 CFR 155.260 (RSS)