Medical records contain a wealth of sensitive patient information, including personal identification details and medical history, making healthcare data significantly valuable. In 2023, 725 data breaches were reported by healthcare organizations, with more than 133 million records being improperly disclosed.
Organizations managing Electronic Protected Health Information (ePHI) in the United States must comply with the Health Insurance Portability and Accountability Act (HIPAA), which protects patient health information. HIPAA regulations are organized into three rules, enabling healthcare organizations and associates to protect ePHI.
HIPAA mandates that healthcare organizations have a comprehensive data backup plan to ensure the maintenance of exact, retrievable copies of ePHI. Understanding HIPAA data backup requirements enables you to be prepared to recover data in case of system failure, disaster, or cyberattack, thus mitigating potential regulatory action and maintaining patient trust. This article highlights key HIPAA backup requirements and data security rules to protect sensitive patient data.
HIPAA and Covered Entities
The Health Insurance Portability and Accountability Act (HIPAA) is a United States legislation that includes patient data privacy and security provisions. The act also includes guidelines and standards for transmitting and protecting sensitive patient health information. The regulation governs the accountability of patient information across various healthcare providers, insurance, and associated entities.
HIPAA regulations enable healthcare providers and associates to secure protected health information (PHI) from unauthorized use and access, ensuring patient privacy.
HIPAA-Covered Entities and Business Associates
A HIPAA-covered entity is any individual or organization directly handling PHI or personal health records (PHRs). These entities include hospitals, pharmacies, nursing homes, and doctors who access PHI to carry out treatment, payment, and other healthcare operations. Health insurance companies, HMOs, and employers providing self-insured health coverage are also considered covered entities with access to PHI.
Business associates provide services that handle ePHI to covered entities and other associates, such as IT service providers, cloud platforms, and consultancies.
HIPAA Three Primary Rules
HIPAA regulations are organized into three distinct rules, which ensure that covered entities safeguard PHI through reasonable physical, administrative, and technical measures.
Privacy Rule
The rule defines standards for protecting patients' personally identifiable health information (PHI) managed by covered entities or their business associates. PHI includes many personal details, such as medical diagnoses, prescriptions, procedures, social security numbers, etc.
Security Rule
The security rule focuses on guidelines specific to securing electronic data. It defines the standards for protecting the electronic PHI (ePHI) by a covered entity.
The Breach Notification Rule
The rule mandates that covered entities and business associates notify organizations of a breach involving unsecured PHI. Once a breach is detected, they must conduct a risk assessment to determine its scope and business impact. If the breach falls under the notification requirement, the organization must send notifications to all relevant stakeholders.
Covered entities and business associates must follow privacy and security rules to protect medical records storage and data retention.
HIPAA Data Backup Requirements
The HIPAA Security Rule establishes standards to safeguard electronic protected health information (ePHI) within healthcare organizations. The key objective of the security rule is to ensure the confidentiality, integrity, and availability of ePHI by implementing a range of safeguards categorized into three main areas.
The three safeguards specified by HIPAA for data backup are physical, technical, and administrative. Let's have a detailed look below:
Physical Safeguards
The objective is to secure physical access to facilities and storage devices that store protected health information. This includes measures like facility access controls, workstation security, device and media controls, and policies governing the movement of hardware containing ePHI within a facility to limit access to only authorized personnel.
Facility Access Control
Healthcare organizations must implement measures to limit physical access to electronic systems to authorized users. Controlled entities should implement contingency operations, facility security plans, access control and validation procedures, and maintenance records to ensure that only authorized people can access the physical facilities storing the data.
Workstation Security
Organizations should implement policies and procedures that govern how workstations are used, including guidelines for securing devices when not in use. They also need to consider the environment or physical attributes of the surroundings of workstations that can access Electronic Protected Health Information.
Tamperproof Logging
According to research, 84% of healthcare organizations reported a cyberattack, and three-fourths of those attacks involved compromises between users and admin accounts. This makes it more important that the systems should have tamperproof automated logging to ensure the availability of reliable audit trails for verification.
Device and Media Control
Organizations must adhere to the specifications for disposal, media reuse, and accountability. They should ensure that media devices are unusable and/or inaccessible after disposal. Before media reuse, organizations need to remove all ePHI. Accountability is most applicable when organizations use portable workstations or devices. It requires proper documentation for the movement of workstations or devices.
Technical Safeguards
Though healthcare organizations can not eliminate the possibility of a data breach, implementing HIPAA technical safeguards can go a long way in mitigating cyber risk. These safeguards involve using technology, policies, and procedures to protect ePHI from unauthorized access and breaches.
Access Controls
Access controls should limit authorized users' access to the minimum information required to perform job functions. This includes multi-factor authentication and role-based access controls to protect patients' data.
United States(U.S) health insurance company - United Health reported the largest medical data breach in U.S. history, impacting around 190 million people. The breach was caused by hackers breaking into Change's systems using a stolen account credential, which was not protected with multi-factor authentication.
Audit Controls
The organization must be able to determine the access control capability of all information systems with ePHI and ensure that access logs can be examined to monitor users' access to ePHI.
Encryption and Security Measures
All data must be secured through encryption both at rest and during transmission to protect sensitive information from unauthorized access.
Data Retention Policies
HIPAA requires healthcare organizations to establish a data retention policy for retaining PHI for at least six years from the date of creation or the date it was last in effect. However, state laws requiring longer retention duration preempt the federal regulation.
Integrity Controls
Covered entities should implement measures to protect ePHI from improper alteration or destruction, including using digital signatures.
Data Transmission Security
Securing data transmission is essential for healthcare organizations, especially with the increasing use of electronic health records (EHRs) and health information exchanges (HIEs). Organizations must protect ePHI during transmission through encryption and secure communication protocols.
Data Redundancy
Organizations must follow the 3-2-1 data backup rule, which refers to keeping three copies of data: one primary and two secondary backups. Two copies of data are stored on different storage media, such as on-premise and external disks, while the third is stored offsite in a remote location or the cloud.
Data Backup Plan
HIPAA mandates that covered entities have a comprehensive data backup plan in place to ensure the maintenance of exact retrievable copies of Electronic Protected Health Information (ePHI).
Administrative Safeguards
Administrative safeguards are administrative policies and procedures governing the protection of electronic protected health information. The policies also cover the conduct of the covered entities or business associate's workforce to safeguard that information. The requirements include:
Security Management Process
A covered entity must have policies and procedures to enable its employees to comply with HIPAA administrative safeguards. Organizations need to implement risk analysis, risk management, sanction policy, and information system activity review for security management.
Disaster Recovery and Contingency Plans
A robust disaster recovery and contingency plan is integral to HIPAA compliance. The plan enables covered entities to mitigate the risks of data loss due to natural disasters, fires, or system failures. The plan includes procedures for restoring ePHI in case of a data breach or disaster. It must be regularly updated to account for the latest regulations, technology innovations, and threats. A data backup plan is the foundation of a disaster recovery and contingency plan and includes details such as backup frequency, storage, etc.
Workforce Security
It has three addressable implementation specifications: authorization and/or supervision, workforce clearance, and termination procedures. For example, after an employee with access to ePHI is terminated, the covered entity should ensure they can no longer access that information. Additionally, administrative safeguards include business associate agreements, maintaining documentation, and security awareness and employee training.
HIPAA Data Backup Best Practices
HIPAA data security's physical, technical, and administrative safeguards include a robust data backup plan. In addition to HIPAA regulations, 21 CFR Part 11 requires healthcare organizations to regularly back up their electronic records to ensure their integrity and accessibility throughout the required retention period. The HIPAA data backup plan for ePHI should follow the guidelines below.
Backup Frequency
The backup frequency should be based on how often your data changes and the criticality of the information. While scheduling your data backups, you should also consider the amount of data loss your organization can tolerate (also known as the recovery point objective).
According to HIPAA regulations, healthcare organizations should back up patient health data at least once a day to protect sensitive information.
Data Encryption
Ensure that all data is processed and stored in an encrypted format to avoid unauthorized access during the backup process. Backed-up data should be encrypted at rest and in transit.
Data Security
Data backups should be managed with proper access controls to maintain data integrity, essentially treating electronic records the same as paper records, requiring them to be readily available for inspection by the FDA.
Regulate Access
Ensure user authentication safeguards, including multi-factor password protection and role-based access controls, are provided to ensure that only authorized personnel can access ePHI.Regularly review backup permissions to regulate data access and ensure only authorized personnel can view or edit backup files. You must also ensure that no ordinary user has permission to modify data and metadata.
Data Backup Testing
You should periodically test your backup process by simulating recovery scenarios to ensure data integrity and the effectiveness of recovery plans.
Data Backup Storage
Backups must be stored in a location distinct from production services and, depending on the record, retained for a finite period—in some cases, six years or more.
Integrate Data Backup with a Disaster Recovery Plan
Your data backup should be part of your disaster recovery (DR) plan tailored to your specific operational requirements and security objectives. At least one backup copy should be stored offsite to protect against local disasters.
Conclusion
If your organization handles PHI and utilizes Salesforce applications, it is critical to diligently adhere to administrative, physical, and technical safeguards rules. A comprehensive data backup plan is essential to mitigate data loss risks while ensuring compliance with legal obligations under HIPAA.
The native Salesforce backup solutions have technical limitations and cost implications that can make HIPPA data backup challenging or incomplete. To make your backup bulletproof, you can complement Salesforce native data backup capabilities with third-party backup solutions like Flosum, which provide technical, administrative, and physical safeguards to protect sensitive patient information. Flosum meets all the requirements of a HIPAA-compliant backup and recovery solution, enabling you to implement stringent security measures, adhere to retention policies, and mitigate risks to ensure business continuity.
Schedule a call with our expert team to learn how we can improve your HIPAA data backup.
Frequently Asked Questions
What are the requirements for a HIPAA-compliant backup?
HIPAA-compliant backups must ensure data confidentiality, integrity, and availability. The organization must encrypt backup data during transfer and storage, regulate access controls, maintain audit logs, and secure storage in compliant environments. Additionally, regularly check data integrity, formulate disaster recovery plans, and ensure proper documentation of policies and processes.
Salesforce HIPAA backup requirements mandate providers to sign Business Associate Agreements (BAAs) to meet the regulation standards.
What Is the Requirement of the HIPAA Privacy Standards?
HIPAA privacy standards require protecting individuals' health information (PHI) by ensuring confidentiality, limiting access to authorized entities, and providing patients with rights over their data.
The privacy rule defines patients' rights to access and amend their ePHI. It specifies guidelines for covered entities and business associates regarding disclosing how data is used and shared and if an unintended disclosure or breach occurs.
How To Make Salesforce HIPAA Compliant?
To make Salesforce HIPAA compliant, enable Salesforce Shield for encryption, monitoring, and audit logs. You must implement strict access controls, enforce secure authentication, and sign a Business Associate Agreement (BAA) with Salesforce.
