What Is the HIPAA Minimum Necessary Rule?
The HIPAA minimum necessary rule is an important part of HIPAA compliance and can help prevent covered entities from accessing more PHI than necessary.
What is the minimum necessary rule?
The minimum necessary rule is a part of the Privacy Rule for HIPAA. This rule requires covered entities to make reasonable efforts to only access the minimum amount of protected health information necessary to fulfill their goal.
What Is HIPAA?
The Health Insurance Portability and Accountability Act (HIPAA) regulates how hospitals, doctor’s offices, insurance companies, and their business partners handle and protect patient information—namely, that which is called protected health information (PHI).
These rules span any place where PHI comes into contact with users, doctors, and patients.
HIPAA is managed by the Department of Health and Human Services and separated into separate sections, known as rules that govern specific aspects of the regulations:
The Privacy Rule
The Privacy Rule is the first rule of HIPAA, and in many ways, the foundation of any rule that comes after it. It defines the organizations that are governed by HIPAA:
- Covered Entities (CE): Hospitals, doctor’s offices, insurance companies, or other organizations directly providing healthcare-related services.
- Business Associates (BA): Any third-party vendor or service provider that works with a CE in a capacity that interfaces with PHI. This can include financial services, data storage services, email, or cloud services.
Furthermore, the Privacy Rule dictates the responsibilities of CEs and BAs. Namely, these organizations must make any and all reasonable efforts to protect the privacy of PHI against unauthorized disclosure to third parties outside of the patient/organization relationship. Under no circumstances are CEs or BAs to allow unauthorized disclosures of PHI, personally identifiable information (PII), or financial information related to healthcare services.
There are some exceptions outlined by the Privacy Rule. These include situations like research, legal requirements, public service, or emergencies that provide contexts where unauthorized disclosure can be justified.
HIPAA Privacy Rule Penalties
Healthcare organizations and business associates risk significant legal, financial, and reputational consequences should they violate the HIPAA Security Rule. Here is a brief overview of those consequences:
Legal: Healthcare organizations and business associates that violate the HIPAA Privacy Rule can face substantial fines and penalties from the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). These penalties can range from $100 per violation to a maximum of $50,000 per violation and can include criminal prosecution and imprisonment for cases involving the intentional disclosure of private health information.
Financial: Violations of the HIPAA Privacy Rule can also have significant cost implications for healthcare organizations and business associates. In addition to the fines from the HHS OCR, the costs of implementing corrective measures that ensure HIPAA compliance can be prohibitive. Furthermore, healthcare organizations and business associates may face legal action from patients whose health information was divulged improperly, subjecting them to potentially significant monetary damages.
Reputational: HIPAA violations also have potentially devastating implications for an organization’s reputation. Any violation of the HIPAA Privacy Rule can lead to negative press and tarnish the reputation of an organization or business associate in the eyes of the public and other stakeholders. Such a tarnished reputation can lead to a reduction in business, loss of customers, and fewer partnerships with other healthcare organizations.
To avoid penalties and ensure HIPAA compliance, healthcare organizations and business associates should implement administrative, physical, and technical safeguards to protect private health information. These safeguards should be tailored to the size, scope, and resources of the organization and include appointing a Privacy Officer to oversee compliance efforts, training staff on HIPAA regulations, and implementing policies and procedures that comply with the HIPAA Privacy Rule. Organizations should also conduct regular risk assessments to identify potential threats and vulnerabilities, and develop action plans to address any issues identified. Finally, organizations should also monitor their compliance efforts to ensure that they remain up to date.
The Security Rule
To facilitate the protections of PHI as defined in the Privacy Rule, HIPAA puts into place security requirements in the Security Rule. This rule breaks down the requirements into three categories:
- Technical Controls: Organizations must implement the technology and systems needed to protect PHI. This includes using HIPAA encryption, proper identity and access management systems, perimeter security systems, hardware and device protection, and other controls.
- Physical Controls: Administrations must restrict access to computer systems containing PHI. This means implementing safeguards and monitoring for physical servers and workstations, visitor logs, protections for physical records, and physical safeguards for laptops and workstations.
- Administrative Controls: Organizations should have documented HIPAA and privacy policies in place. These policies should include training programs and operations for regular activities like employee onboarding and termination.
The specific technical implementation of these rules is left purposely vague so that the rule can evolve with new threats and technologies. The technical controls that are sufficient for HIPAA compliance requirements with this rule are defined in the National Institute of Standards and Technology Special Publication 800-66: “An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act Security Rule.”
HIPAA Security Rule Penalties
Healthcare organizations and business associates risk significant legal, financial, and reputational consequences should they violate the HIPAA Security Rule. Here is a brief overview of those consequences:
Legal: Healthcare organizations and business associates that violate the HIPAA Security Rule can be subjected to civil and criminal penalties. Civil penalties can range from $100 to $50,000 per violation, with a maximum annual penalty of $1.5 million. Criminal penalties can range from a $50,000 fine and one year of imprisonment to a $250,000 fine and 10 years of imprisonment.
Financial: HIPAA violations can be expensive for healthcare organizations and business associates. In addition to the fines and penalties imposed by the government, organizations may incur additional costs to resolve the breach, such as hiring an attorney, implementing new security measures, and providing free credit monitoring services to affected individuals.
Reputational: HIPAA violations can damage an organization’s reputation, leading to a loss of customers, a reduction in revenue, and an overall decrease in public trust. Organizations that violate the HIPAA Security Rule may also be subject to negative media attention, which can further damage their reputation.
Healthcare organizations and business associates can take the following steps to avoid HIPAA Security Rule violations:
- Develop comprehensive HIPAA policies and procedures and ensure they are regularly reviewed and updated as needed
- Train all staff members on HIPAA regulations and compliance measures
- Implement technical safeguards such as encryption, authentication, and access control to protect electronic PHI
- Establish a security incident response plan
- Review third-party contracts to ensure that vendors comply with the HIPAA Security Rule
- Perform regular security risk assessments
- Monitor system activity and audit logs for unauthorized access or use of PHI
- Create a culture of compliance within the organization
The Breach Notification Rule
In incidents where a HIPAA breach has happened, a CE or BA must follow a set of notification and disclosure procedures to notify affected patients and the public more broadly.
In cases where a hacker breaks into a healthcare system, or any incident where PHI could possibly be compromised, CEs and BAs must undertake some basic steps:
- Disclosure: The organization must make reasonable efforts to notify affected patients using their existing contact information. If a significant number of patients cannot be reached directly, then the organization must take more public steps to provide notification, including updates on a public website and a toll-free telephone hotline.
- Public Notification: If the breach affects a large number of people, then the organization must publicly disclose the breach to media outlets in the affected jurisdictions.
- Government Notification: The organization must also notify the Office of the Secretary of HHS.
The Omnibus Rule
The Omnibus Rule is an addition to HIPAA regulations passed in 2013 to modernize some of its aspects against new technologies and threats. Some of the major changes introduced in the Omnibus Rule include:
- A requirement that, if a patient should request it, an organization shall not disclose PHI to the patient’s health plan unless otherwise required by law.
- Organizations may never use PHI for marketing purposes.
- BAs, previously facing limited accountability for HIPAA violations, now face full scrutiny for HIPAA compliance (or lack thereof). This means that, should they violate HIPAA in service of a CE, they are fully responsible.
What Is the Minimum Necessary Rule?
Unlike the other rules listed here, the minimum necessary rule isn’t a standalone part of HIPAA, but rather a smaller section under the Privacy Rule that defines how CEs and BAs may use PHI.
The minimum necessary rule standard states that covered entities and business associates must make efforts to limit the use and disclosure of PHI to the “minimum necessary” needed to accomplish intended purposes.
Like other aspects of HIPAA, the meaning of “reasonable” is left flexible, and in some ways left to the judgment of the governed organization (with proper justification). This means, generally, that if a company can justify their minimum necessary information processing and then find themselves disclosing PHI, their potential penalties will be much less severe than if they simply refused to make any attempt to meet the rules.
There are some exceptions to this rule:
- A provider may provide information above and beyond their processing needs for the purposes of providing treatment
- If the processing or disclosure falls under any exceptions of disclosure in the privacy rule
- Any disclosures legally made to the Secretary of HHS
- Disclosures that are required by law
To maintain adherence to the minimum necessary rule, companies should have well-documented policies around their data needs and how, exactly, they will use PHI. Furthermore, they should have clearly defined role-based access controls in place to limit who may access PHI and for what purposes. These security protocols must be documented in an organization’s cyber risk management strategy.
In addition to the above, organizations need to work with employees to implement training programs, embed record-keeping and audit logs, and clarify sanctions against the company and employees for any breach.
Ensure Compliance With Minimum Necessary PHI Processing With Kiteworks
The core of meeting requirements for minimum necessary PHI processing are protecting PHI from unauthorized disclosure, limiting access so only individuals who absolutely need the data can use it, and documenting and logging all activity around that data to ensure that the PHI isn’t leaking despite HIPAA security controls.
To meet these requirements, your organization cannot rely on manual systems. Instead, you must implement the right platforms that can securely store and transmit PHI while automating audit logging, security controls, and compliance analytics.
Kiteworks-enabled Private Content Networks include the following features:
The Kiteworks platform has out-of-the-box compliance reporting for industry and government regulations and standards, such as the Health Insurance Portability and Accountability Act (HIPAA), Payment Card Industry Data Security Standard (PCI DSS), SOC 2, and the General Data Protection Regulation (GDPR.)
In addition, Kiteworks touts certification and compliance with various standards that include, but are not limited to, FedRAMP, FIPS (Federal Information Processing Standards), and FISMA (Federal Information Security Management Act). Kiteworks also facilitates compliance with CMMC 2.0 (Cybersecurity Maturity Model Certification) and is assessed to PROTECTED level controls by IRAP (Infosec Registered Assessors Program).
- Audit logging: With the Kiteworks platform’s immutable audit logs, organizations can trust that attacks are detected sooner and maintain the correct chain of evidence to perform forensics. Since the system merges and standardizes entries from all the components, Kiteworks’ unified syslog and alerts save security operations center teams crucial time while helping compliance teams to prepare for audits.
- SIEM integration: Kiteworks supports integration with major security information and event management solutions, including IBM QRadar, ArcSight, FireEye Helix, LogRhythm, and others. It also has the Splunk Forwarder and includes a Splunk App.
- Visibility and management: The CISO Dashboard in Kiteworks gives organizations an overview of their information: where it is, who is accessing it, how it is being used, and if data being sent, shared, or transferred complies with regulations and standards. The CISO Dashboard enables business leaders to make informed decisions while providing a detailed view of compliance.
- Single-tenant cloud environment: File transfers, file storage, and user access occur on a dedicated Kiteworks instance, deployed on-premises, on an organization’s Infrastructure-as-a-Service resources, or hosted as a private single-tenant instance by Kiteworks in the cloud by the Kiteworks Cloud server. This means no shared runtime, shared databases or repositories, shared resources, or potential for cross-cloud breaches or attacks.
Discover how Kiteworks supports your HIPAA compliance efforts by requesting a custom demo based on your organization’s specific requirements.
Additional Resources
- Blog Post Managed File Transfer & HIPAA-compliant Solutions
- Blog Post HIPAA Compliant
- Blog Post Top HIPAA-Compliant Forms [Secure Solutions]
- Blog Post HIPAA Compliance Encryption
- Blog Post HIPAA Compliant Emails