Skip to main content


U.S. flag
      An official website of the United States government
              Here’s how you know
        Here’s how you knowDot gov**Official websites use .gov**
                 A **.gov** website belongs to an official government organization in the United States.
                  HTTPS**Secure .gov websites use HTTPS**
                 A **lock** (A locked padlock) or **https://** means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites. 
  Menu Close
          Enter the terms you wish to search for.
    Search
        








  
  
    

  
      

                                      About HHS
    
                        
                              
      
      
      Programs & Services
    
                        
                              
      
      
      Grants & Contracts
    
                        
                              
      
      
      Laws & Regulations                  
Health Information Privacy
  HIPAA for Individuals
    
                        
                                            
      
      
      Filing a Complaint
    
                        
                                            
      
      
      HIPAA for Professionals
    
                        
                                            
      
      
      Newsroom

              

    



Breadcrumb
    HHS
                              HIPAA Home
                              For Professionals
                              Regulatory Initiatives
                              Request for Information (RFI) on Recognized Security Practices and Sharing Civil Money Penalties and Monetary Settlements with Harmed Individuals


    

    

    Navigate to:
  HIPAA for Professionals
    
                                    
                                            
            
      
      
      
      Regulatory Initiatives
    
                                                  
                                                                  
            
      
      
      
      Privacy
                                            
            
            Summary of the Privacy Rule
    
                                                  
                                            
            
      
      
      
      Guidance
    
                                                  
                                            
            
      
      
      
      Combined Text of All Rules
    
                                                  
                                            
            
      
      
      
      HIPAA Related Links
    
                                                  
                                                                  
            
      
      
      
      Security
                                            
            
            Summary of the Security Rule
    
                                                  
                                            
            
      
      
      
      Security Guidance
    
                                                  
                                            
            
      
      
      
      Cyber Security Guidance
    
                                                  
                                                                  
            
      
      
      
      Breach Notification
                                            
            
            Breach Reporting
    
                                                  
                                            
            
      
      
      
      Guidance
    
                                                  
                                            
            
      
      
      
      Reports to Congress
    
                                                  
                                            
            
      
      
      
      Regulation History
    
                                                  
                                                                  
            
      
      
      
      Compliance & Enforcement
                                            
            
            Enforcement Rule
    
                                                  
                                            
            
      
      
      
      Enforcement Process
    
                                                  
                                            
            
      
      
      
      Enforcement Data
    
                                                  
                                            
            
      
      
      
      Resolution Agreements
    
                                                  
                                            
            
      
      
      
      Case Examples
    
                                                  
                                            
            
      
      
      
      Audit
    
                                                  
                                            
            
      
      
      
      Reports to Congress
    
                                                  
                                            
            
      
      
      
      State Attorneys General
    
                                                  
                                                                  
            
      
      
      
      Special Topics
                                            
            
            HIPAA and Part 2
    
                                                  
                                            
            
      
      
      
      Change Healthcare Cybersecurity Incident FAQs
    
                                                  
                                            
            
      
      
      
      HIPAA and COVID-19
    
                                                                
                                                                  
            
      
      
      
      HIPAA and Reproductive Health
                          
            
            HIPAA and Final Rule Notice
    
                                                  
                                            
            
      
      
      
      HIPAA and Telehealth
    
                                                  
                                            
            
      
      
      
      HIPAA and FERPA
    
                                                  
                                            
            
      
      
      
      Research
    
                                                  
                                            
            
      
      
      
      Public Health
    
                                                  
                                            
            
      
      
      
      Emergency Response
    
                                                  
                                            
            
      
      
      
      Health Information Technology
    
                                                  
                                            
            
      
      
      
      Health Apps
    
                                                  
                                                                  
            
      
      
      
      Patient Safety
                                            
            
            Statute & Rule
                          
            
            PSQIA Statute
    
                                                  
                                            
            
      
      
      
      Patient Safety Rule
    
                                                  
                                            
            
      
      
      
      Enforcement
    
                                                  
                                            
            
      
      
      
      Guidance
    
                                                  
                                                                  
            
      
      
      
      Covered Entities & Business Associates
                                            
            
            Business Associate Contracts
    
                                                  
                                            
            
      
      
      
      Business Associates
    
                                    
                                            
            
      
      
      
      Training & Resources
    
                                    
                                            
            
      
      
      
      FAQs for Professionals
    
                                    
                                            
            
      
      
      
      Other Administrative Simplification RulesText resize icon

                    




Request for Information (RFI) on Recognized Security Practices and Sharing Civil Money Penalties and Monetary Settlements with Harmed Individuals Under the HITECH Act








  
  
    

  
      



On April 6, 2022, OCR released a RFI seeking input from the public on two requirements of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), as amended in 2021.  OCR is seeking public comment on the following provisions of law:

**Recognized Security Practices.**Section 13412 of the HITECH Act requires HHS to take into consideration certain recognized security practices of covered entities (health plans, health care clearinghouses, and most health care providers) and business associates when determining potential fines, audit results, or other remedies for resolving potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule pursuant to an investigation, compliance review, or audit.  Public Law 116-321 went into effect when it was signed into law on January 5, 2021.

	One of the primary goals of this provision is to encourage covered entities and business associates to do “everything in their power to safeguard patient data.”

	To achieve this goal, Congress sought to “[incentivize] healthcare entities to adopt strong cybersecurity practices by encouraging the Secretary of HHS to consider entities' adoption of recognized security practices when conducting audits or administering HIPAA fines." The statute requires OCR to take into consideration in certain Security Rule enforcement and audit activities where a covered entity or business associate has adequately demonstrated that recognized security practices were “in place” for the prior 12 months.**Civil Money Penalty (CMP) and Settlement Sharing.** Section 13410(c)(3) of the HITECH Act requires HHS to establish by regulation a methodology under which an individual harmed by a violation of the HIPAA Privacy, Security, or Breach Notification Rules may receive a percentage of any CMP or monetary settlement collected with respect to such offense.

	Section 13140(d)(1) of HITECH requires that OCR base determinations of appropriate penalty amounts on the nature and extent of the violation and the nature and extent of the harm resulting from such violation. The HITECH Act does not define “harm,” nor does it provide direction to aid HHS in defining the term. The RFI solicits public comment on the types of harms that should be considered in the distribution of CMPs and monetary settlements to harmed individuals, discusses potential methodologies for sharing and distributing monies to harmed individuals, and invites the public to submit alternative methodologies.OCR encourages comments from all stakeholders, including patients and their families, HIPAA covered entities and their business associates, consumer advocates, health care professional associations, health information management professionals, health information technology vendors, and government entities.

Individuals seeking more information about the RFI or how to provide written or electronic comments to OCR should visit the Federal Register to learn more:

View the RFI in the Federal Register
	View the RFI Press Release
	View the GAO Letter on Models for the Distribution of Civil Money PenaltiesPlease note that comments must be submitted by June 06, 2022 in order to be considered.

###

                    
  


Content created by Office for Civil Rights (OCR) Content last reviewed March 1, 2023Back to top
    Contact HHS
    
                        
                                            
      
      
      Careers
    
                        
                                            
      
      
      HHS FAQs
    
                        
                                            
      
      
      Nondiscrimination NoticeHHS Archive
    
                        
                                            
      
      
      Accessibility Statement
    
                        
                                            
      
      
      Privacy Policy
    
                        
                                            
      
      
      Viewers & PlayersBudget/Performance
    
                        
                                            
      
      
      Inspector General
    
                        
                                            
      
      
      Web Site Disclaimers
    
                        
                                            
      
      
      EEO/No Fear ActFOIA
    
                        
                                            
      
      
      The White House
    
                        
                                            
      
      
      USA.gov
    
                        
                                            
      
      
      Vulnerability Disclosure Policy
        Sign Up for Email Updates

Receive the latest updates from the Secretary, Blogs, and News Releases.

Sign Up
  HHS Headquarters
          200 Independence Avenue, S.W.
                  Washington, D.C. 20201
                  Toll Free Call Center: 1-877-696-6775​