Guide to HIPAA Compliant File Transfers - Part 1
In this post, we'll be talking about the specific standards that lead to HIPAA compliant file transfers. This is a continuation of another post, so if you haven't read Part I yet, you might want to click that link first.
HIPAA standards affecting file transfers
As shown in our previous post, the HIPAA standards that impact file transfer systems can be found in the Technical Safeguards of the Security Rule. The Security Rule is documented in 45 CFR (Code of Federal Regulations) Part 160 and Part 164, Subparts A and C, with the Technical Safeguards themselves specifically found in section 164.312.
The standards that fall under Technical Safeguards as well as the specific sections that contain their definitions and corresponding requirements include the following:
Access Control (§ 164.312(a)(1)) - Covered entities must implement technical policies and procedures for electronic information systems that maintain ePHI to allow access only to those persons or software programs that have been granted sufficient access rights.
Audit Controls (§ 164.312(b)) - Covered entities must implement hardware, software, and procedural mechanisms that record and examine activity in information systems that contain or use ePHI.
Integrity (§ 164.312(c)(1)) - Covered entities must implement policies and procedures to protect ePHI from improper alteration or destruction.
Person or Entity Authentication (§ 164.312(d)) - Covered entities must implement procedures to verify that a person or entity seeking access to ePHI is the one claimed.
Transmission Security (§ 164.312(e)(1)) - Covered entities must implement technical security measures to guard against unauthorized access to ePHI that is being transmitted over an electronic communications network.
Each of these standards come with a set of instructions for implementing them known as Implementation Specifications. An Implementation Specification is classified either as Required or Addressable.
If an implementation specification is Required, then you will have to implement policies and procedures that would satisfy that particular implementation specification. On the other hand, if it is Addressable, then you will have to analyze the specification to determine whether it is reasonable and appropriate in protecting your ePHI data from possible threats and hazards.
If, based on your analysis, you decide that it is not necessary to implement the implementation specification, you must document the reason for your decision. In addition, if in the course of your analysis, you come across a reasonable and appropriate alternative measure, then you must implement that measure.
Let's now take a quick look at each standard's implementation specifications and discuss how such specifications may be implemented on your file transfer system.
Unique User Identification (Required) - People who use your file transfer service should be assigned a unique user identifier like a username or a number. This will help you track each user's activity when the user is logged into your system. It will also help you in holding that user accountable for functions he performs while logged in.
Emergency Access Procedure (Required) - You must have in place procedures that will allow you to obtain the ePHI found in your system in the event of an emergency situation wherein your file transfer system is rendered inoperative.
Automatic Logoff (Addressable) - Your system must be capable of terminating a session after a predetermined period of inactivity is reached. Users sometimes forget to logoff after completing a file transfer, leaving your system vulnerable to unauthorized entry. An automatic logoff feature will prevent unauthorized users from gaining access that way.
Encryption and Decryption (Addressable) - This may refer to ePHI data stored in directories on your file transfer server. By encrypting ePHI data found there, you can render those data useless to unauthorized personnel. Even when an unauthorized person gains access to those encrypted data, he won't be able to make heads or tails out of them.
Audit Controls (Required)
Mechanism to Authenticate ePHI (Addressable) - The integrity of ePHI data should be preserved at all times. Improperly altered or destroyed ePHI can put patients' safety at risk. Because unauthorized data changes can be caused by a variety of reasons ranging from human errors to electronic failures, your file transfer system should have a mechanism that will enable you to check whether your ePHI data has undergone any unauthorized changes.
Person or Entity Authentication (Required)
Your system must have a way of knowing whether a person who wants to gain access to it is in fact the person he or she claims to be. The most common methods of authentication typically require users to present a proof of identity such as a password, PIN, smart card, token, key, or biometrics.
Integrity Controls (Addressable) - This is similar to the Integrity standard discussed earlier. The only difference is that the previous discussion was focused on data at rest, e.g. ePHI stored in your FTP server hard disks, while this one here is aimed at data in motion, i.e., ePHI being transmitted over a network. So, for example, your system must support network communications protocols that ensure that data sent is the same as data received.
Encryption (Addressable) - Again, this is similar to the Encryption/Decryption implementation specification under the Access Control standard, except that this one refers to data in motion. So for example, your file transfer system should support file transfer protocols like FTPS or SFTP.
So there you have it. Those are the standards and implementation specifications of the HIPAA regulation that impact file transfer systems. You're now ready for the last part of this article. That's where we'll discuss the steps to achieve HIPAA compliant file transfers.
Guide to HIPAA Compliant File Transfers - Part 3