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

Current version
45 CFR 155.260 (as amended September 2016)
Published 6 September 2016. source
Status
In force
Next deadline
None announced
Who must comply
Health insurance Exchanges, and the non-Exchange entities (such as agents, brokers, issuers, Navigators and contractors) that access or collect personally identifiable information for functions agreed with an Exchange. source 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
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 dates
  1. Compliance date for ARC-AMPE Version 1.0, the CMS security and privacy controls for Exchanges and partner entities
  2. CMS released ARC-AMPE Version 1.0, which supersedes MARS-E
  3. Section 155.260 took effect with the Exchange establishment rule

Amendments

  1. 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

  2. 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

  3. 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

  4. 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

  5. Correction of the Exchange establishment rule Errata

    Corrected wording in paragraphs (a)(3) and (d) of section 155.260. source

Show 1 older amendment
  1. 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.

Up to $36,083 per use or disclosure

Knowingly or willfully disclosing protected information from an Exchange; statutory amount $25,000, shown as the 2025 maximum adjusted penalty in the HHS inflation table. source source

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

  1. Law text 45 CFR 155.260 – Privacy and security of personally identifiable information
  2. Law text 45 CFR 155.280 – Oversight and monitoring of privacy and security requirements
  3. Law text 45 CFR 155.285 – Civil penalties for improper use or disclosure of information
  4. Guidance ARC-AMPE Volume I (Version 1.02, April 2025)
  5. Template CMS Marketplace regulations and guidance (ARC-AMPE Volume II overlays)
Show 1 more document
  1. Law text 45 CFR 102.3 – HHS civil monetary penalty inflation table

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)