What are Technical Safeguards?
HIPAA technical safeguards protect PHI and have become a major part of any HIPAA Privacy program. Technical safeguards are important due to the constant technology advancements in the health care industry. They are key elements that help to maintain the safety of EPHI as the internet changes.
One of the greatest challenges of healthcare organizations face is that of protecting electronic protected health information (EPHI). This would include protection of electronic health records, from various internal and external risks. The answer to the question, What are Technical Safeguards? They are the tools covered entities use to protect ePHI.
What we cover:
- The Security Rule
- Comply with Technical Safeguards
- Implementing “The Security Rule”
- Technical Standards
- Standard: Access Controls
- Standard: Audit Controls
- Standard: Integrity
- Standard: Person or Entity Authentication
- Standard: Transmission Security
- Cybersecurity & Technical Safeguards
- Texting Protected Health Information
- Texting Patient Orders
- Working from Home
The Security Rule
The Security Rule was adopted to implement provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). One of the key facets of the rule are the Technical Safeguards. These are meant to protect EPHI and are a major part of any HIPAA Security plan. The HIPAA Security Rule indicates that technical safeguards are the technology and the policy and procedures for its use that protect electronic protected health information and control access to it.
All covered entities and business associates must use technical safeguards to reasonably and appropriately implement necessary standards to protect PHI. All entities must decide which measures are reasonable and appropriate for their organization to accomplish the task.
Cybersecurity is the art of protecting electronic health information, networks, devices and data form unauthorized access or criminal use and the practice of ensuring confidentiality, integrity, and availability of information. Using cybersecurity to protect EPHI is a key feature of Technical Safeguards in the Security Rule of HIPAA.
Technical safeguards are key protections due to constant technology advancements in the health care industry. They are key elements that help to maintain the safety of EPHI as the internet changes.
One of the greatest challenges of healthcare organizations face is that of protecting electronic protected health information (EPHI). This includes protection of electronic health records, from various internal and external risks. To best reduce risks to EPHI, covered entities must implement Technical Safeguards.
There are many risks, and these come in various forms. Among these are malware erasing your entire system, a cyber-attacker breaching your system and altering files, a cyber-hijacker using your computer to attack others, or an attacker stealing or freezing your patient data in return for money. There is no guarantee that even with the best precautions you will prevent this, but there are steps you can take to minimize the chances.
Reasonable Safeguards for PHI are precautions that a prudent person must take to prevent a disclosure of Protected Health Information.
To protect all forms of PHI,verbal, paper, and electronic, providers must apply these safeguards. They help prevent unauthorized uses or disclosures of PHI.
In addition safeguards must be part of every privacy compliance plan. Organizations must share this with all members of the organization.
An organization may face multiple challenges as it attempts to protect EPHI. These issues must all be considered as they may originate from inside or outside the organization. It is important for any organization to perform a full risk analysis to protect the organization from such a variety of threats.
We present several examples of cyberthreats in healthcare you must be ready to address. This will help you as you develop your Security Program. First, we must understand Technical Safeguards of the Security Rule.
Comply with Technical Safeguards
The Security Rule defines technical safeguards as the technology and the policy and procedures for its use that protect electronic protected health information and control access to it.
What are Technical Safeguards? Another way of answering this is as follows:
The Security Rule is based on several fundamental concepts. These concepts include:
- Technology neutrality
No specific requirements for types of technology to implement are identified. The Rule allows a covered entity to use any security measures that allows it to reasonably and appropriately implement the standards and implementation specifications. A covered entity must determine which security measures and specific technologies are reasonable and appropriate for implementation in its organization based on their size and resources.
Solutions vary in nature depending on the organization. The Security Rule requires that reasonable and appropriate measures must be implemented and that the General Requirements of the rule must be met. That is the most important requirement.
Implementing “The Security Rule”
In the Security Standards under General Rules, Flexibility of Approach, provides the entity with important guidance for focusing on decisions a covered entity must consider when selecting security measures such as technology solutions. Once an organization has completed the required risk analysis and risk management process the entity will be able to make the appropriate informed decisions.
The Rule allows the use of security measures but there is no specific technology that is required. The guidance given is that the entity should reasonably and appropriately implement the Standards and implementation specifications.
Each Security Rule standard is a requirement. Many of the standards contain implementation specifications. An implementation specification is a more detailed description of the method or approach covered entities can use to meet the requirements of a particular standard.
If an implementation specification is described as required, the specification must be implemented. The concept of “addressable implementation specifications” was developed to provide covered entities additional flexibility with respect to compliance with the security standards. In meeting standards that contain addressable implementation specifications, a covered entity will do one of the following for each addressable specification: (a) implement the addressable implementation specifications; (b) implement one or more alternative security measures to accomplish the same purpose; (c) not implement either an addressable implementation specification or an alternative.
The covered entity’s choice must be documented. The covered entity must decide whether a given addressable implementation specification is a reasonable and appropriate security measure to apply within its particular security framework.
Standard: Access Controls
In the first safeguard the Security Rule defines access in CFR §164.304 as the ability or the means necessary to read, write, modify, or communicate data/information or otherwise use any system resource. (This definition applies to access as used in this subpart, not as used in subpart E of this part [the HIPAA Privacy Rule]).
This first standard is meant to outline the ability or the means necessary to read, write, modify, or communicate data/information or otherwise use any system resource.
It provides users with rights and/or privileges to access and perform functions using programs, files information systems and applications. Ideally it should provide access to the minimum necessary information required to perform a duty within the organization. This access should be granted based upon a set of access rules the covered entity implements as part of Information Management Access outlined in the Administrative Safeguards section of the Rule.
The standard requires a covered entity to:
Implement technical policies and procedures for electronic information systems that maintain electronic protected health information to allow access only to those persons or software programs that have been granted access rights as specified in Information Access Management.
There are many different combinations of access control methods and technical controls that can be used to accomplish these objectives. Whatever method is used it should be appropriate for the role and/or function of the workforce member.
There are four implementation specifications:
- Unique User identification (Required)
- Emergency Access Procedure (Required)
- Automatic Logoff (Addressable)
- Encryption and Decryption (Addressable)
1. Unique User Identification (Required)
According to this implementation specification, a covered entity is directed to do the following:
Assign a unique name and/or number for identifying and tracking user identity.
A user identification is a process used to identify a specific user of an information system, typically by name and/or number. This identifier will allow an entity to track specific user activity when that user is logged into an information system. By doing so It will enable an entity to hold users accountable for functions performed on information systems with EPHI when logged into those systems.
There are no specified formats described by the Rule for identification. A Covered entity must determine the best user identification strategy based on their workforce and their operations.
2. Emergency Access Procedure (Required)
Under this implementation specification the organization is asked to:
Establish (and implement as needed) procedures for obtaining necessary electronic protected health information during an emergency.
There must be procedures which are well documented and instructions that will allow an entity to have access to EPHI during emergency situations. An entity must determine the types of situation that would require emergency access to information systems. Examples to consider would be loss of power or hijacking of data.
3. Automatic Logoff (Addressable)
Under this implementation specification the organization is asked to:
Implement electronic procedures that terminate an electronic session after a predetermined time of inactivity.
Automatic logoff from a system is a common approach to protecting inadvertent access to workstations. It is an effective way to prevent unauthorized users from accessing EPHI on a workstation left unattended.
4. Encryption and Decryption (Addressable)
Under this implementation specification the covered entity is asked to consider:
Implement a mechanism to encrypt and decrypt electronic protected health information.
This is an addressable system and should be put into effect when it is a reasonable and appropriate safeguard for a covered entity. Encryption is a method of converting messages into encoded text using an algorithim.
By using this technique there is low probability anyone other than the intended recipient who has the key may read the information. There are many ways to encrypt or technologies to protect data from being inappropriately accessed. It is up to the entity to decide if this is necessary.
When the Security Rule was enacted they recognized the rapid advances in technology. Consequently, it would be very difficult to give guidelines that change regularly. For this reason, they chose not to require specific safeguards.
It is up to the organization to do a careful risk assessment. Based on this, they may create the appropriate mechanism to protect ePHI.
Presently the use of encryption of ePHI is an effective tool. It is a good safeguard for the safe transmission of email and texts through the cloud. In many cases this has become the standard for the transmission of sensitive data in healthcare and in the business world.
Standard: Audit Controls
Audit controls are key in monitoring and reviewing activity in the system to protect its EPHI.
The standard requires a covered entity to:
Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information.
Information systems must have some level of audit control with the ability to provide reports. These controls are useful for auditing system activity in the face of a security violation.
The Security Rule does not identify specific data to be gathered by the audit controls. It is up to the covered entity to consider this after a risk analysis and to determine the most reasonable and appropriate for audit control for their systems that contain EPHI.
Integrity is defined in the Security Rule, as the property that data or information have not been altered or destroyed in an unauthorized manner.
The standard requires a covered entity to:
Implement policies and procedures to protect electronic protected health information from improper alteration or destruction.
The reason for this standard is to establish and implement policies and procedures for protecting EPHI from being compromised regardless of the source. It will help prevent work force members from making accidental or intentional changes and thus altering or destroying EPHI. It may also help prevent alterations caused by electronic media errors or failures.
There is one addressable implementation specification.
1. Mechanism to Authenticate Electronic Protected Health Information (Addressable)
If it is reasonable and appropriate a covered entity must:
Implement electronic mechanisms to corroborate that electronic protected health information has not been altered or destroyed in an unauthorized manner.
A covered entity must do a risk analysis and determine from this the various risks to the integrity of EPHI. This will help define the security measures necessary to reduce the risks.
Standard: Person or Entity Authentication
Authenticating the individual who has access to the system is very important in the establishment of technical safeguards.
This standard requires a covered entity to:
Implement procedures to verify that a person or entity seeking access to electronic protected health information is the one claimed.
This implementation specification requires a system of identification to verify that a person is who they are before getting access to the system. There are many ways of accomplishing this such as passwords, PINs, smart cards, tokens, keys or biometrics.
The mechanism used will depend on the organization. Most organizations rely on a password or PIN. If the credential entered match those of the system, the user is then allowed access.
Standard: Transmission Security
It is important to guard all transmissions of electronic protected health information.
This standard requires a covered entity to:
Implement technical security measures to guard against unauthorized access to electronic protected health information that is being transmitted over an electronic communications network.
Once a covered entity has completed a risk analysis they will review and understand the current method used to transmit EPHI. Consider if it is sent by email, internet, a network or texting. Once these methods are reviewed the entity can determine the best way to protect EPHI.
There are two implementation specifications:
- Integrity Controls
1. Integrity Controls (Addressable)
Based on a risk analysis If this is an implementation specification that is reasonable and appropriate, the covered entity must:
Implement security measures to ensure that electronically transmitted electronic protected health information is not improperly modified without detection until disposed of.
Integrity in the context of this implementation focuses on making sure the EPHI is not improperly modified during transmission. This may be accomplished by using network protocols that confirm the data that was sent is the data is received.
2. Encryption (Addressable)
After a risk analysis if this implementation specification is a reasonable and appropriate safeguard the covered entity must:
Implement a mechanism to encrypt electronic protected health information whenever deemed appropriate.
As mentioned earlier under the Access Control standard, encryption is a method of converting messages into an encoded or unreadable text that is later decrypted into comprehensible text. This is an addressable implementation, similar to that under Encryption and Decryption.
Encryption works only if the sender and receiver are using the same or compatible technology. The Security Rule allows covered entities the flexibility to determine when, with whom and what method of encryption to use.
Cybersecurity & Technical Safeguards
Using cybersecurity to protect PHI is a key feature of HIPAA. Electronic protected health care information or EPHI is at increased risk from many sources:
- Foreign hackers looking for data to sell ? usually on the dark web
- Ransomware attacks that lock up data until a ransom payment is received
- Phishing schemes that lure the user into clicking a link or opening an attachment to deploy malicious software; and
- Spear phishing ?a targeted attack on a specific person that appears to come from a legitimate source usually instructing a transfer of funds.
- The internet of Things or IoT will allow the interconnection of devices as a means for virus or malware to enter our systems.
What You Can Do to Protect EPHI
- First, know how to spot phishing emails.
- Learn how to use strong passwords, two factor authentication and encryption.
- Finally, have policies, procedures and safeguards in place to protect EPHI and know who to report an incident to in your organization.
Prepare for Cyberattacks
In the case of a cyberattack or similar emergency an entity must:
- Execute its response and mitigation procedures and contingency plans.
- Report the time to other law enforcement agencies.
- An entity should report all cyber threat indicators to federal and information-sharing and analysis organizations.
- Finally, it must report the breach to OCR as soon as possible, but not later than 60 days after the discovery of a breach affecting 500 or more individuals.
The OCR considers all mitigation efforts taken by the entity during in any breach investigation. For instance, such efforts include voluntary sharing of breach-related information with the appropriate agencies. Remember in the event of a cyberattack it is critical to comply with breach reporting requirements.
Texting Protected Health Information
How do you handle texting in your organization?
There are two different types of texting. The first type of texting is what we usually accomplish using our phone and carrier and is also known as Short Message Service (SMS). This is the default app on our phone that many people use to send and receive texts every day and is not secure. It should never be used to send EPHI.
The second type is app based and is used by healthcare providers (mostly doctors and nurses) to communicate to one another on patient-related care. It can also be used by providers to communicate with patients and is secure. There are certain requirements that must be met.
To be compliant secure texting needs to meet certain technical standards for HIPAA compliance:
- Encryption of message data in transit and at rest
- Reporting/auditability of message content
- Passcode enforcement
- Permissions management capabilities
If safeguards like these are in place, PHI can be sent with a minimum of risk. Because SMS is an unencrypted channel one might presume an entity cannot send PHI. This is actually not true because encryption is not mandated according to the Security Rules.
Healthcare organizations must determine whether encryption is reasonable and an appropriate safeguard, in protecting PHI. It is possible to use alternative safeguards If encryption is not deemed reasonable and appropriate by the covered.
In 2013 the HIPAA Omnibus Final Rule allowed healthcare providers to communicate PHI with patients through unencrypted e-mail as long as the provider does the following.
- Warn their patients that texting is not secure
- Gain the patient’s authorization
- Document the patient’s consent
This did not clear providers to communicate PHI to one another using unencrypted e-mail. Notably, the rule did not mention anything about SMS, which is somewhat frustrating as SMS is the most widely adopted communication channel. Some interpret the rule as applying to SMS as well because both are unencrypted electronic channels. Others want more clarity.
At a Health Information Management Conference in March of 2017 the OCR director said healthcare providers could text message their patients with PHI. However, the provider must warn the patient that it is not secure. In addition, the provider must obtain and document patient authorization to receive texts.
Recent Guidance on Sharing PHI Safely
The Centers for Medicare and Medicaid Services or CMS oversees the Conditions of Participation and Conditions for Coverage. CMS issued a memo on healthcare provider texting protected health information safely on December the 28th of 2017. Most importantly the takeaways are:
Texting Protected Health Information
CMS permits texting of patient information among members of the health care team. Above all, the platform must be secure and encrypted. As a result, it minimizes the risks to patient privacy and confidentiality. Most importantly, HIPAA regulations, the Conditions of Participation and the Condition for Coverage require this as a safeguard.
Texting Patient Orders
Regardless of the platform, CMS prohibits the practice of texting of patient orders. Above all, the provider is not in compliance with the Conditions of Participation or Conditions for Coverage if he or she texts patient orders to a member of the care team.
In December 2016, The Joint Commission, in collaboration with the Centers for Medicare & Medicaid Services (CMS), decided to reverse a May 2016 position to allow secure texting for patient care orders and issued the following recommendations:
- All health care organizations should have policies prohibiting the use of unsecured text messaging, also known as short message service, from a personal mobile device for communicating protected health information.
- The Joint Commission and CMS agree that computerized provider order entry (CPOE), which refers to any system in which clinicians directly place orders electronically, should be the preferred method for submitting orders, as it allows providers to directly enter orders into the electronic health record (EHR).
- In the event that a CPOE or written order cannot be submitted, a verbal order is acceptable on an infrequent basis.
In December 2017, the Joint Commission issued a clarification explicitly stating the use of Secure Texting for patient orders is prohibited. Providers should opt for the use of Computerized Provider Order Entry (CPOE) as the preferred method of order entry. CMS insists that a physician or Licensed Independent Practitioner (LIP) should enter orders into the medical record via a handwritten order or via CPOE.
When using this system, orders are immediately downloaded into the provider?s electronic health records (EHR). Moreover, this method is preferred as the order would be dated, timed, authenticated and promptly placed in the medical record.
For more information from Health IT.gov, Computerized Provider Order Entry (CPOE)
Finally, using cybersecurity to protect PHI remains the cornerstone to protecting all ePHI which all organizations should address in today’s healthcare climate.
Most importantly, it is important to know that having security policies is not enough. An organization must observe and follow these policies to protect patients and the entity.
Consequently, all organizations must routinely review their plan, train their employees on HIPAA and monitor that everyone follows the plan.
There is a new rule which is getting much attention from the Office for Civil Rights called the Information Blocking Rule. It requires covered entities and business associates to share electronic protected health with patients on request.
Working From Home and HIPAA
Since the advent of COVID a large section of the workforce has been forced to work from home. In most situations this has worked well except for the fact that Protected Health Information (PHI) is now at greater risk than ever before. Organizations are now placed in an awkward situation as they try to follow the HIPAA Privacy Rule while allowing employees to establish home offices.
There are many HIPAA privacy concerns in the remote setting not experienced while working in the office. Devices are frequently more susceptible to malware attacks and precautions must be taken. Phishing attempts will be even more common when working remotely. While working at home an employee’s spouse, family members or visitors might be able to view or access a patient’s PHI in a way that they would not be able to if the employee was working on-site.
There are many privacy and security measures that need to be implemented to address the concerns and risks to PHI in a work-from-home environment. There are many steps an employee and an IT Department can take to abide by the HIPAA Rule in remote settings and protect PHI.
Safeguards for the Home Setting:
Physical safeguards are very important in the home setting. PHI can be protected from the view of friends and family by locking the screen when you walk away, use a privacy screen on your computer, restrict access to the devices that contain PHI, and be careful not to mention PHI aloud in a place where someone could overhear.
Bring Your Own Device (BYOD) may become an issue in the home setting as it increases the need for technical safeguards. When employees use their own devices, there is a significant increase in the risk of a HIPAA breaches.
- Create a Bring Your Own Device (BYOD) Agreement, with clear usage rules for employees.
- Covered entities can also require employees to use specific brands and versions of devices to access PHI.
- Make sure all devices that are used in a remote work environment are equipped with the latest software updates and security configurations.
- Ensure that laptops are equipped with firewalls and antivirus software to protect network access.
- Be sure to encrypt and password protect all personal devices that may be used to access PHI such as cellphones, tablets, and laptops.
- Utilize multi-factor authentication on all platforms (if this isn’t possible, ensure that remote staff are using strong passwords).
Create Safe Networks
Prepare home networks to work effectively with your mobile devices ensuring they are fully functional and protected using your home Wi-Fi network. There are steps one can take to ensure this happens.
Require that the home wireless router’s default password is updated and ensure that WiFi is encrypted. Newer types of encryptions are WPA (Wi-Fi protected access) and the WPA2 which implements the latest security standards. These require the use of a password to access the network.
Establish and update Virtual Private Networks (VPNs). A VPN protects your internet connection and privacy online. It creates an encrypted setting for your information, keeps your identity hidden and even allows you to use public Wi-Fi hotspots safely.
IT should monitor and test VPN limits to prepare for any increases in the number of users. Team members should also be aware of the potential need to make changes to adjust to their bandwidth requirements. Train employees to disconnect from the company VPN when their daily work is complete. This can be enforced by implementing measures like IT configuring timeouts.
Staying in Contact Safely
Most employees who work for home will rely on meeting apps to maintain contact with clients and other team members by means of video calls. Some of these remote access apps include FaceTime, Google Hangouts, Zoom, Skype, Teams, or Facebook Messenger video chat. It is important that providers enable all privacy and encryption modes available on these apps.
Organizations are required to complete business associate agreements with these organizations. Make sure to contact your app provider to sign a business associate agreement.
An effective protection for PHI a company can use is encryption. Encrypt all PHI before it is transmitted in any form. This will help to prevent unauthorized disclosure of PHI.
Don’t send PHI via email unless it is the only option and in these cases be sure to use all tools to encrypt emails.
If copying PHI to external media, make sure that you only use flash drives, hard drives or other materials that have been approved by the company. These external media devices should be encrypted for best security.
Only print PHI if necessary & then be sure to keep all forms of PHI safe in a lockable file cabinet or safe. If printed information is shredded, make sure to dispose of it immediately. Provide safes or lockable file cabinets for any employees that must store paper copies of PHI in their home offices.
Reassess your security protocols frequently.
The new work from home setting will be a challenge for many organizations and will require special attention to effectively protect PHI and adhere to HIPAA compliance. Based on the experience of many companies it is likely this is a system which will be around for a long time and remote workers will remain as a major workforce.
Despite these challenges we must continue to maintain a safe working environment for the home office to safeguard PHI. Using the methods outlined it is likely an organization can stay out of harm’s way and follow the HIPAA Privacy Rule. For more information Contact us.
HIPAA technical safeguards are important due to technology advancements as they help to protect EPHI in today’s environment. It is crucial for all covered entities and business associates who deal with electronic PHI to review their use of Technical Safeguards to be fully in compliance.
We are often asked, what are Technical Safeguards? We are here to help guide you through all the questions you may have about the HIPAA-Security Rule.