Encrypted External Storage – HIPAA Compliant external Hard Drives

HIPAA Compliant External Devices
There are a variety of Open Source applications that can be used to securely encrypt external storage devices in keeping with HIPAA Standards(hard disk drives, USB drives, etc.) but it is important to understand the guidelines set forth by the National Institute of Standards and Technology (NIST) first. Specifically the Special Publication 800-111, Guide to Storage Encryption Technologies for End User Devices. HIPAA compliant encryption can easily be added to any external storage device.


Full Disk Encryption
For a computer that is not booted, all the information encrypted by FDE is protected, assuming that pre-boot authentication is required. When the device is booted, then FDE provides no protection; once the OS is loaded, the OS becomes fully responsible for protecting the unencrypted information. The exception to this is when the device is in a hibernation mode; most FDE products can encrypt the hibernation file.

Virtual Disk and Volume Encryption
When virtual disk encryption is employed, the contents of containers are protected until the user is authenticated for the containers. If single sign-on is being used for authentication to the solution, this usually means that the containers are protected until the user logs onto the device. If single sign-on is not being used, then protection is typically provided until the user explicitly authenticates to a container. Virtual disk encryption does not provide any protection for data outside the container, including swap and hibernation files that could contain the contents of unencrypted files that were being held in memory. Volume encryption provides the same protection as virtual disk encryption, but for a volume instead of a container.

File/Folder Encryption.
File/folder encryption protects the contents of encrypted files (including files in encrypted folders) until the user is authenticated for the files or folders. If single sign-on is being used, this usually means that the files are only protected until the user logs onto the device. If single sign-on is not being used, then protection is typically provided until the user explicitly authenticates to a file or folder. File/folder encryption does not provide any protection for data outside the protected files or folders, including swap and hibernation files that could contain the contents of unencrypted files that were being held in memory. File/folder encryption software also cannot protect the confidentiality of filenames and other file metadata, which itself could provide valuable information to attackers (for examples, files that are named by Social Security number).

Encryption for purposes of HIPAA is simply to the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key and such process or key has not been breached. The guidance identifies two encryption processes recognized by the National Institute of Standards and Technology (NIST) as rendering protected health information unusable, unreadable or indecipherable. For data at rest, the acceptable processes are those that are consistent with NIST Special Publication 800-111, Guide to Storage Encryption Technologies for End User Devices. Valid encryption processes for data in motion are those that comply with Federal Information Processing Standards 140-2.


Covered entities and business associates must remember that rendering PHI unusable, unreadable or indecipherable to unauthorized individuals as defined in the guidance is not a substitute for compliance with HIPAA’s privacy and security regulations or other federal or state health information privacy and security laws.

2009 HIPAA Regulations – Security and Privacy Measures

Most health care organizations are now actively interested in implementing the security and privacy measures called for by the HIPAA regulations and are wondering how to get started with this complex, long-lived, and expensive task. This document was developed to help organizations that handle PHI address the HIPAA security and privacy regulations.


Awareness is important at all levels of the organization, but at the early stages it is most essential for middle and upper management. HIPAA planning cannot move forward in any substantial way until the stakeholders of the organization are actively engaged in creating plans and organizational approaches and developing cost estimates. HIPAA is a compliance issue; treat it as one.

It is important for everyone, especially senior managers, to understand that HIPAA is a
regulatory compliance project rather than simply an IT initiative. Treating it as a compliance issue is much more likely to lead to the appropriate organization, attention level, and allocation of resources. Resources need to be in the budget cycle for the upcoming fiscal year in order to meet the aggressive timeline.

Standardize your Approach:
Many of the security and privacy requirements can best be met by creating guidelines, principles, templates, and checklists that are then used consistently in each domain (e.g., system, department, division); This will save staff time by creating an efficient, consistent approach. Consistency will make the system more understandable to those who work across various domains and will make the approach more defensible to those with oversight roles (e.g., risk managers, external auditors, JCAHO).

Success Requires Cultural Change:
To run a successful HIPAA-compliant operation, most organizations will have to go through a cultural change in how they manage privacy and security until the new methods become systematic and reflexive. Responses that are not common now will need to become so for a large percentage of the workforce. Many of the HIPAA requirements point up the need for this kind of “new common sense.” Widespread cultural change requires commitment and leadership across an organization.