Does HIPAA and the HITECH Act Impact Medical Device and Pharma Companies?

The Question:

Are medical device or pharmaceutical companies designated as a qualifying entity subject to HIPAA and HITECH?

The Answer:

Yes.

Classifying the entity

Are medical device or pharmaceutical companies designated as a qualifying entity subject to HIPAA and the HITECH Act? Yes. In general, a provider that “transmits any health information in electronic form in connection with a transaction covered by this subchapter” is considered a covered entity. Moreover, according to the 45 CFR §160.103(2)(ii)(3), “a covered entity may be a business associate of another covered entity.” In fact, CMS recognized that as a government agency, it is subject to HIPAA, the HITECH Act and related rules in an October 2012 report issued by the Office of the Inspector General, “CMS Response to Breaches and Medical Identity Theft.”

In turn, a business associate, as defined by the HIPAA Rules, is “a person who performs functions or activitieson behalf of, or certain services for, a covered entity that involve the use or disclosure of protected health information” (emphasis added). A subcontractor is a person who contracts with a business associate and stores, handles or transmits PHI. Regardless, under Section 164.308(b) of the Security Rule and 164.502(e) of the Privacy Rule, a covered entity or business associate is required to enter into an arrangement known as a business associate agreement to provide parameters and some legal protection when a contracted entity is handling PHI.

Effective Feb. 18, 2010, Section 13408 of the HITECH Act provides that health information organizations, e-prescribing gateways, vendors of personal health records and other persons that facilitate data transmission and require access to PHI, regardless of their status as a covered entity, business associate or subcontractor, are subject to business associate agreements in accordance with the HIPAA Rules.

Therefore, medical device and pharmaceutical companies can be classified as a qualifying entity subject to HIPAA and the HITECH Act. As such, they are subject to handling, storing and transmitting in accordance with the requisite laws and regulations. The consequences from civil and criminal monetary penalties alone are significant. Since the HITECH Act expressly expanded HIPAA’s requirements to business associates and subcontractors, the same standards for access to medical records, business associate agreements and other provisions equally apply.

Patient access rights

The tension between patients wanting to have access to their health data from a medical device, which is implanted in them, and a medical device company is highlighted. According to a representative of a medical device maker quoted in the article, “Federal rules prohibit giving Ms. Hubbard’s data to anyone but her doctor and hospital. Our customers are physicians and hospitals.” In general, 45 C.F.R. §164.524, Access of Individuals to Protected Health Information, sets forth the parameters of the HIPAA Privacy Rule. Included in these standards are the circumstances for providing protected health information to a patient and exceptions. Nothing in the scenario of the PHI being transmitted from a patient’s implant to a medical device company, who would be classified as a business associate in this instance invokes an exception to deny the patient’s request.

Section 13410(d) of the Health Information Technology for Economic and Clinical Health Act authorizes penalties to be assessed for violations of the Privacy Rule. In February 2011, HHS issued a Final Notice of Determination and held Cignet Health, a business associate, liable for $4.3 million in civil monetary penalties when they denied 41 patients access to their medical records. As OCR Director Georgina Verdugo indicated, “covered entities and business associates must uphold their responsibility to provide patients with access to their medical records, and adhere closely to all of HIPAA’s requirements.” And, “The U.S. Department of Health and Human Services will continue to investigate and take action against those organizations that knowingly disregard their obligations under these rules.” This area should be considered in drafting business associate agreements. Therefore, business associates such as Medtronic are required to release the PHI to the patient requesting the information, unless one of the exceptions is met, and the patient is informed.

“How Does HIPAA and the HITECH Act Impact Medical Device and Pharma Companies?”. Becker Hospital Review, US. Retrieved December 20, 2018.

Memo: subsidiary websites

The question

We have our [redacted] website but just found that our substance abuse team has created another website that just specifically address addiction and the services provided. The only association it has with our office is a small little logo at the bottom of the page. And the telephone number listed goes directly to a staff members cell phone. Do you find this a issue?

The answer

Strictly regarding subsidiary websites, there is no violation or problem that arises from this issue alone. Many hospitals and practices enable the use of separate websites when services are differentiated substantially from the parent organization.

However, the problem with the [redacted, subsidiary] team website is that this website was created without the prior express authorization of the parent organization. The website was created and is managed outside of the normal reach of the parent organization and the project was undertaken in violation of the organization’s policies and procedures (this is assumed, based on unseen policies and procedures).

The inclusion of a staff member’s cell phone number on the site as the primary method for contacting the substance abuse team creates a problem with chain of custody. A patient suffering from substance abuse might leave sensitive information in a voicemail left on the staff member’s cell phone. Without being able to guarantee any assurances as to the privacy and security of this potentially sensitive information, such an incident could be considered an unauthorized disclosure.

Depending on the organization’s policies and procedures regarding a BYOD (bring your own device) policy and mobile device management, this creates a continual vulnerability for sensitive information to be disclosed, unintentionally or otherwise.

Additionally, the substance abuse website might not sufficiently publicize the organization’s notice of privacy practices (this is assumed, based on unseen website).

Suggested corrective action

The website should immediately be brought under the direct control of the parent organization, be made so that the site is not publicly accessible until corrective action is completed, and evaluated by the designated individuals responsible for website maintenance. Any deficiency should be brought into compliance in accordance with the organization’s policies and procedures. The staff responsible for acting outside of the organization’s policies and procedures should be made aware of the problems their actions have caused, along with appropriate disciplinary sanctions.

Memo: reasonably anticipated threats to protected health information

What are possible threats to protected health information (PHI), electronic (ePHI) or otherwise?

The US Department of Health and Human Services defines a threat as “the potential for a person or thing to exercise (accidentally trigger or intentionally exploit) a specific vulnerability.” Threats are broken down into three categories:

  • Environmental: referring to immediate physical environments, such as offices or data centers
  • Natural: referring to weather, natural disasters, mass human events, and Acts of God
  • Human: referring to individuals who could cause harm, either inadvertently or negligently, or intentionally and maliciously

Aligned Risk Management has identified the following reasonably-anticipated threats to the security, privacy and availability of ePHI.

  1. Environmental Threats
    1. Internet outage: Failure of application server to connect to internet, failure of DNS servers to resolve server domain name, upstream connection failure, and other internet outages.
    2. Power outageFailure of power systems at the data center, failure of power supply to the data center, and other power outages.
    3. Hardware failureFailure of any hardware component of the server or data center where the application is hosted. Refers to failures caused by wear, age, design flaws, and other inherent hardware weaknesses.
    4. Software failureFailure of any application, operating system or other software component to operate as intended. Includes malware infections, data corruption, functional failures.
    5. Site pollutionFire, spills, accidents, etc.
  2. Natural Threats
    1. Floods, earthquakes, tornadoes, landslides, etc.Any unpredictable large-scale threat over which humans have no control. Also includes mass human events, such as war, terror attacks, strikes, epidemics, alien invasions, zombie apocalypse, etc.
  3. Human Threats
    1. Internal threatsAuthorized users, staff, Business Associates, trusted advisors, etc. The least dramatic but most common threats to the security, privacy and availability of ePHI.
      1. Inadvertent disclosure of ePHIUnintentional action by authorized user or failure of Application that inadvertently discloses any ePHI to any unauthorized user
      2. Inadvertent data entry, modification or deletionUser error. Accidental and unintentional action or omission by an authorized user that causes damage to the security or availability of ePHI
      3. Malicious disclosure of ePHI by authorized userDeliberate disclosure by authorized user who intends to obtain some personal gain or to cause harm
      4. Malicious destruction of ePHI by authorized userDeliberate sabotage by authorized user who intends to cause harm
    2. External threatsEx-employees, hackers, thieves, etc.
      1. Unauthorized observation of ePHIUnauthorized person is able to observe improperly-controlled ePHI
      2. Unauthorized person gains access using genuine credentialsAttacker successfully logs into a controlled system using a genuine username and password or other credentials of an authorized user
      3. Technological attack against a controlled systemAttacker exercises a technological vulnerability of an ePHI system still controlled by the covered entity
      4. Technological attack outside any control or responseAttacker gains indefinite physical control of an ePHI system and is able to exercise vulnerabilities without detection or intervention by covered entity
      5. Social engineeringAttacker uses psychological manipulation to induce authorized users to act against security policies or divulge confidential information
      6. Malicious destruction of ePHI by unauthorized userDeliberate sabotage by attacker who intends to cause harm
  4. Compliance Gaps
    1. Civil liability for failure to implement HIPAA-mandated specificationFailure to implement or adequately document certain required polices and procedures
    2. Civil liability for failure to follow documented policiesFailure to implement or adequately document certain required polices and procedures

Memo: about two-factor authentication

Two-factor authentication (2FA), or multi-factor authentication, is a security process in which the user provides two means of identification from separate categories of credentials; one is something memorized, such as a security code or password, and the other is typically a physical token, such as a card or a previously-authenticated smartphone.

A common example of two-factor authentication is the ATM card most consumers are familiar with. In order to authorize a transaction, the user must present the ATM card (a physical token) and also enter a PIN (a memorized secret). Neither the card alone nor the PIN alone will suffice to authorize a transaction, and it is unlikely that an attacker could obtain both simultaneously.

Stolen passwords are a very common vector for online attacks. Two-factor authentication can drastically reduce the effectiveness of password-related exploits, because stealing a password is not enough to give an attacker access to protected information.

True two-factor authentication requires that the factors be chosen from separate categories of credentials. The three commonly recognized categories are

  • “something you know” (e.g., a password)
  • “something you have” (e.g., a pre-registered smartphone), and
  • “something you are” (e.g., a fingerprint)

Most two-factor authentication today works by leveraging the second category in the form of a physical token or pre-registered smartphone. Smartphone-based solutions are popular since they work with a device most users already carry with them and protect zealously.

Numerous inexpensive 2FA solutions, some based on open standards, are gaining rapid adoption:

  • U2F security keys, an open standard for inexpensive USB tokens, industry leaders, like Yubico and Google.
  • Smartphone apps, usually free, that implement the open standard TOTP protocol (see below). Google Authenticator and Symantec VIP are commonly used.
  • Proprietary solutions, including Microsoft Azure and Duo.

Pre-registered knowledge tokens (PKTs), commonly known as “security questions,” are of the same category as passwords (“something you know”) and cannot be combined with passwords to provide true two-factor authentication.

Two-factor authentication does not replace passwords. Good password practices are still essential, but two-factor authentication can significantly reduce the risk of weak passwords.

Some 2FA solutions work by transmitting a one-time password over a different communication channel, such as via SMS to a pre-registered mobile phone. This is true two-factor authentication, but poor security practices by mobile service providers introduce the risk that the one-time password could be intercepted by an attacker.

More secure solutions can generate one-time passwords without having to transmit them, thus eliminating any risk that they could be intercepted. Transmitting one-time passwords via SMS has been deprecated by the latest NIST cybersecurity guidelines. Non-transmitting solutions should be preferred whenever available.

Cryptographic certificates, when generated and installed by properly authorized administrators, are of the same category as physical devices (“something you have”) and can be used in combination with passwords to implement two-factor authentication. Although a certificate is only data (like a password), it is tied closely to the physical device on which it is installed and it is difficult for the user to access, memorize, or inadvertently breach. The threat of unauthorized cloning does need consideration, but in general, enrolling a trusted device by installing a cryptographic certificate can be a cost-effective and very secure way to implement two-factor authentication.

 

Memo: requirements of a Business Associate Agreement (BAA)

According to the US Department of Health and Human Services, a written contract between a covered entity and a business associate must:

  1. establish the permitted and required uses and disclosures of protected health information by the business associate;
  2. provide that the business associate will not use or further disclose the information other than as permitted or required by the contract or as required by law;
  3. require the business associate to implement appropriate safeguards to prevent unauthorized use or disclosure of the information, including implementing requirements of the HIPAA Security Rule with regard to electronic protected health information;
  4. require the business associate to report to the covered entity any use or disclosure of the information not provided for by its contract, including incidents that constitute breaches of unsecured protected health information;
  5. require the business associate to disclose protected health information as specified in its contract to satisfy a covered entity’s obligation with respect to individuals’ requests for copies of their protected health information, as well as make available protected health information for amendments (and incorporate any amendments, if required) and accountings;
  6. to the extent the business associate is to carry out a covered entity’s obligation under the Privacy Rule, require the business associate to comply with the requirements applicable to the obligation;
  7. require the business associate to make available to HHS its internal practices, books, and records relating to the use and disclosure of protected health information received from, or created or received by the business associate on behalf of, the covered entity for purposes of HHS determining the covered entity’s compliance with the HIPAA Privacy Rule;
  8. at termination of the contract, if feasible, require the business associate to return or destroy all protected health information received from, or created or received by the business associate on behalf of, the covered entity;
  9. require the business associate to ensure that any subcontractors it may engage on its behalf that will have access to protected health information agree to the same restrictions and conditions that apply to the business associate with respect to such information; and
  10. authorize termination of the contract by the covered entity if the business associate violates a material term of the contract. Contracts between business associates and business associates that are subcontractors are subject to these same requirements.

“Business Associate Contracts”. United States Department of Health and Human Services. Retrieved September 6, 2018.

Memo: use of email by healthcare providers to discuss health issues and treatment with patients

From Health and Human Services

“Yes. The Privacy Rule allows covered health care providers to communicate electronically, such as through e-mail, with their patients, provided they apply reasonable safeguards when doing so. See 45 C.F.R. § 164.530(c). For example, certain precautions may need to be taken when using e-mail to avoid unintentional disclosures, such as checking the e-mail address for accuracy before sending, or sending an e-mail alert to the patient for address confirmation prior to sending the message. Further, while the Privacy Rule does not prohibit the use of unencrypted e-mail for treatment-related communications between health care providers and patients, other safeguards should be applied to reasonably protect privacy, such as limiting the amount or type of information disclosed through the unencrypted e-mail. In addition, covered entities will want to ensure that any transmission of electronic protected health information is in compliance with the HIPAA Security Rule requirements at 45 C.F.R. Part 164, Subpart C.

“Note that an individual has the right under the Privacy Rule to request and have a covered health care provider communicate with him or her by alternative means or at alternative locations, if reasonable. See 45 C.F.R. § 164.522(b). For example, a health care provider should accommodate an individual’s request to receive appointment reminders via e-mail, rather than on a postcard, if e-mail is a reasonable, alternative means for that provider to communicate with the patient. By the same token, however, if the use of unencrypted e-mail is unacceptable to a patient who requests confidential communications, other means of communicating with the patient, such as by more secure electronic methods, or by mail or telephone, should be offered and accommodated.

“Patients may initiate communications with a provider using e-mail. If this situation occurs, the health care provider can assume (unless the patient has explicitly stated otherwise) that e-mail communications are acceptable to the individual. If the provider feels the patient may not be aware of the possible risks of using unencrypted e-mail, or has concerns about potential liability, the provider can alert the patient of those risks, and let the patient decide whether to continue e-mail communications.”

Patient Consent

Communicating with a patient via email is subject to the patient’s consent to be communicated with through that channel. If appropriate procedures are in place regarding email collection, the act of the patient providing that email address to the provider can be considered tacit consent.

Patients may initiate communications with a provider using email. If this situation occurs, the health care provider can assume that email communications are acceptable to the individual, unless the patient has explicitly stated otherwise. If the provider feels the patient may not be aware of the possible risks of using unencrypted email, or has concerns about potential liability, the provider can alert the patient of those risks, and let the patient decide whether to continue email communications.

Taking email address from public lists or spam lists is never acceptable.

Electronic Communication

The HIPAA Privacy Rule does allow covered healthcare providers to communicate electronically, such as through email, with their patients. This assumes that reasonable safeguards are applied when doing so. (45 C.F.R. § 164.530(c))

Certain precautions must be taken when using email to avoid unintentional disclosures. Precautions such as ensuring the accuracy of an email address before sending or sending an email alert to the patient for address confirmation prior to sending the message that contains protected health information are important.

Further, while the Privacy Rule does not prohibit the use of unencrypted email for treatment-related communications between healthcare providers and patients, other safeguards should be applied to reasonably protect privacy. These safeguards might include limiting the amount or type of information disclosed through unencrypted email. These safeguards can be addressed through appropriately drafted policies and procedures.

Patient Portal

Always try to encourage patients to use the patient portal when possible. This should be considered the prefered method of communication between patient and provider.

Disclaimer

When communicating by email, it is a best-practice to include appropriate disclaimers. The best method for ensuring the inclusion is to incorporate the disclaimer as a footer below the signature line, thus guaranteeing that the disclaimer is included on every email.

Summary

Yes, email is an acceptable method of communication for healthcare providers, as long as the patient approves of using email for this purpose. Approval can be as simple as asking for the patient’s email address to use for sending forms. If the patient provides the address, this can be considered tacit consent. Always document these actions in policies and procedures.

Communication via the patient portal should be the preferred method of communication.

Warn the patient that email is an inherently insecure method of communication. Do this when the patient requests to be contacted through email and again in the initial email.

This article contains direct quotes and information from the United States Department of Health and Human Services.

“Does the HIPAA Privacy Rule permit health care providers to use e-mail to discuss health issues and treatment with their patients?”. United States Department of Health and Human Services. Retrieved September 6, 2018.

Memo: IP address as a second factor of authentication

Properly implemented, we consider a known IP address to be an effective second factor. As far as it represents a physical location, an IP address is of the category Something You Are. Almost like a bio-metric.

Of course, it all depends on how well that IP address’ network is protected. If anyone can walk into your client’s waiting room, plug into an Ethernet port, and get a connection, so much for the second factor. And if anyone can connect to the VPN with nothing but a password, the IP address degrades down to Something You Know, and there goes your second factor.

The good news for you is that if either of those things happens, it constitutes a breach of your client’s systems and controls. Likewise, protecting passphrases is the responsibility of the client. So about the only way a malicious actor could exploit your authentication controls would be by first breaching a client system. I call that sitting pretty.

You have probably heard that is possible to spoof an IP address. True, it is not that hard to make incoming traffic appear to be originating from a false IP address, but it is very difficult to ex-filtrate data back to that spoofed IP address, especially with SSL on the pipe. For any realistic threat model, you can consider IP spoofing to be effectively impossible.

So go for it! It’s not as perfect as trusted device but I’d say it beats face recognition. I think you can call this true two-factor authentication, but it does make some assumptions about network security.

Memo: SOC vs NIST

NIST SP 800-30: Guide for Conducting Risk Assessments

NIST Special Publication 800-30 provides guidance for conducting risk assessments of federal information systems and organizations, amplifying the guidance in Special Publication 800-39. Risk assessments, carried out at all three tiers in the risk management hierarchy, are part of an overall risk management process—providing senior leaders/executives with the information needed to determine appropriate courses of action in response to identified risks.

NIST SP 800-53: Recommended Security Controls for Federal Information Systems and Organization

Everyone interested in advancing design and planning of IT systems must become knowledgeable of the accomplishments of NIST by reading their Special Publication 800-series reports. The 800-series reports on ITL’s research, guidelines, and outreach efforts in information system security, and collaborative activities with industry, government, and academic organizations. The NIST Special Publication 800-53 “Recommended Security Controls for Federal Information Systems and Organization” list pages of specific controls that would be considered in the preparation of a standardized list of IT system controls for the private sector.

NIST SP 800-66: An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule

The HIPAA Security Rule specifically focuses on the safeguarding of electronic protected health information (EPHI). All HIPAA covered entities, which include some federal agencies, must comply with the Security Rule, which specifically focuses on protecting the confidentiality, integrity, and availability of EPHI, as defined in the Security Rule. The EPHI that a covered entity creates, receives, maintains, or transmits must be protected against reasonably anticipated threats, hazards, and impermissible uses and/or disclosures.

Special Publication 800-66 Revision 1, which discusses security considerations and resources that may provide value when implementing the requirements of the HIPAA Security Rule, was written to:

  • Help to educate readers about information security terms used in the HIPAA Security Rule and to improve understanding of the meaning of the security standards set out in the Security Rule.
  • Direct readers to helpful information in other NIST publications on individual topics addressed by the HIPAA Security Rule.
  • Aid readers in understanding the security concepts discussed in the HIPAA Security Rule. This publication does not supplement, replace, or supersede the HIPAA Security Rule itself.

Service Organization Controls (SOC)

The American Institute of Certified Public Accounts (AICPA) has developed and adopted a set of guidelines and regulations for CPA audits in response the requirements of the Gramm-Leach-Bliley Act entitled, Service Organization Controls (SOC).  SOC is divided into two general types of audits SOC 1 and SOC 2 that are described on this site in detail.  SOC  is very specific as to the types of assessments that are to be made for each type of audit. SOC guidelines and regulations do not define the controls to be evaluated as part of an accounting audit to the same depth as controls identified by NIST.

SOC 1 audits according to the requirements of SSAE No. 16 reports  ”On Controls at a Service Organization” that is processing private and nonpublic data that is personal for it’s customers. The controls obviously would vary differently in approach even though there would be some overlap.  Standardizing would require developing different categories of controls for each type of audit.

SOC 2 audits deal with five different concerns: security, availability, integrity, confidentiality, and privacy. There are specific controls that come into play for each of these areas include overlap of controls to prevent possible financial theft, timely transmission, intrusion/manipulation, limited access and nondisclosure.

Concluding Notes

SOC guidelines and regulations do not define the controls to be evaluated as part of an accounting audit to the same depth as controls identified by NIST.

Aligned Risk Management follows NIST SP 800-30, the framework for conducting risk assessments, and evaluates and reports on controls aligned to NIST SP 800-53 and NIST SP 800-66.

This article contains direct quotes and information from the National Institute of Standards and Technology (NIST), Integrated Accounting Services.

“SP 800-30: Guide for Conducting Risk Assessments”. National Institute of Standards and Technology. Retrieved September 4, 2018.

“SP 800-66: An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule”. National Institute of Standards and Technology. Retrieved September 4, 2018.

“NIST Special Publication 800-53”. National Institute of Standards of Technology. Retrieved September 4, 2018.

“Information Technology Laboratory”. Integrated Accounting Services. Retrieved September 4, 2018.

Memo: HIPAA log retention requirements

The subtle distinction between HIPAA medical records retention and HIPAA record retention can cause confusion when discussing HIPAA retention requirements.

There is No HIPAA Medical Records Retention Period

The reason the Privacy Rule does not stipulate how long medical records should be retained is because there is no HIPAA medical records retention period. Each state has its own laws governing the retention of medical records, and – unlike in other areas of the Healthcare Insurance, Portability and Accountability Act – HIPAA does not pre-empt them.

Consequently, each Covered Entity and Business Associate is bound by the laws of the state with regard to how long medical records have to be retained rather than any specific HIPAA medical records retention period. The states´ retention periods can vary considerably depending on the nature of the records and to whom they belong. For example:

  • In Florida, physicians must maintain medical records for five years after the last patient contact, whereas hospitals must maintain them for seven years.
  • In Nevada, healthcare providers are required to maintain medical records for a minimum of five years, or – in the case of a minor – until the patient is twenty-three years of age.
  • In North Carolina, hospitals must maintain patients´ records for eleven years from the date of discharge, and records relating to minors must be retained until the patient is thirty.

The HIPAA Retention Requirements

Although there are no HIPAA retention requirements for medical records, there is a requirement about how long other HIPAA-related documents should be retained. This is covered in CFR §164.316(b)(1), which states Covered Entities must maintain the policies and procedures implemented to comply [with HIPAA] and records of any action, activity or assessment.

CFR §164.316(b)(2)(i) stipulates the documents must be retained for a minimum of six years from when the document was created, or – in the event of a policy – from when it was last in effect. Therefore if a policy is implemented for three years before being revised, a record of the original policy must be retained for a minimum of nine years after its creation.

The list of documents subject to the HIPAA retention requirements is extensive depending on the nature of business conducted by the Covered Entity or Business Associate. The following list is an example of the most common type of documents but, for example, health plans and healthcare clearing houses do not issue Notices of Privacy Practices, so would not be required to retain copies of them:

  • Notices of Privacy Practices.
  • Authorizations for the Disclosure of PHI.
  • Risk Assessments and Risk Analyses.
  • Disaster Recovery and Contingency Plans.
  • Business Associate Agreements.
  • Information Security and Privacy Policies.
  • Employee Sanction Policies.
  • Incident and Breach Notification Documentation.
  • Complaint and Resolution Documentation.
  • Physical Security Maintenance Records.
  • Logs Recording Access to and Updating of PHI.
  • IT Security System Reviews (including new procedures or technologies implemented).

Contains information obtained from HIPAA Journal.

“Clarifying the HIPAA Retention Requirements”. HIPAA Journal. Retrieved September 3, 2018.

HIPAA Security Rule Standards and Implementation Specifications

HIPAA is a set of standards introduced by the U.S. Congress in 1996. The Act consists of rules governing protected health information (PHI) including Security, Privacy, Identifiers, and Transactions and Code Sets. The purpose of the HIPAA Security Rule is to promote the protection and privacy of sensitive PHI used within the healthcare industry by organizations called “covered entities.” As a result of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, both covered entities and business associates are now accountable to the United States Department of Health and Human Services (HHS) and individuals for appropriately safeguarding private patient information.

The HIPAA Security Rule Standards and Implementation Specifications has four major sections, created to identify relevant security safeguards that help achieve compliance: 1) Physical; 2) Administrative; 3) Technical; and 4) Policies, Procedures and Documentation Requirements.

Organizations must implement reasonable and appropriate solutions and management policies and procedures to comply with HIPAA technical standards and implementation specifications. It’s important to perform a formal security risk assessment for each of the safeguards in the HIPAA Security Rule. Management’s decisions related to risk aversion and tolerance must be documented in the security risk assessment to identify potential compliance gaps. For many organizations, it is difficult to determine how the Rule applies. Navigating the type of technologies and processes that are needed to achieve compliance can be challenging.

Under the HIPAA Security Rule, implementation of standards is required, and implementation specifications are categorized as either “required” (R) or “addressable” (A). For required specifications, covered entities must implement the specifications as defined in the Security Rule. For addressable specifications, a covered entity must assess whether the implementation of the specification is reasonable and appropriate for its environment and the extent to which it is appropriate to protect ePHI. Following the security risk assessment, the covered entity must either implement the addressable specification, or document why it would not be reasonable and appropriate to implement and identify alternative and/or compensating safeguards as reasonable and appropriate.

Administrative Safeguards

  • 164.308(a)(1)(ii)(A) Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity.
  • 164.308(a)(1)(ii)(B) Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with §164.306(a).
  • 164.308(a)(1)(ii)(C) Apply appropriate sanctions against workforce members who fail to comply with the security policies and procedures of the covered entity.
  • 164.308(a)(1)(ii)(D) Implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports.
  • 164.308(a)(2) Identify the security official who is responsible for the development and implementation of the policies and procedures required by this subpart [the Security Rule] for the entity.
  • 164.308(a)(3)(ii)(A) Implement procedures for the authorization and/or supervision of workforce members who work with electronic protected health information or in locations where it might be accessed.
  • 164.308(a)(3)(ii)(B) Implement procedures to determine that the access of a workforce member to electronic protected health information is appropriate.
  • 164.308(a)(3)(ii)(C) Implement procedures for terminating access to electronic protected health information when the employment of a workforce member ends or as required by determinations made as specified in paragraph (a)(3)(ii)(B) [the Workforce Clearance Procedure] of this section.
  • 164.308(a)(4)(ii)(A) If a health care clearinghouse is part of a larger organization, the clearinghouse must implement policies and procedures that protect the electronic protected health information of the clearinghouse from unauthorized access by the larger organization.
  • 164.308(a)(4)(ii)(B) Implement policies and procedures for granting access to electronic protected health information, for example, through access to a workstation, transaction, program, process, or other mechanism.
  • 164.308(a)(4)(ii)(C) Implement policies and procedures that, based upon the entity’s access authorization policies, establish, document, review, and modify a user’s right of access to a workstation, transaction, program, or process.
  • 164.308(a)(5)(ii)(A) Periodic security updates.
  • 164.308(a)(5)(ii)(B) Procedures for guarding against, detecting, and reporting malicious software.
  • 164.308(a)(5)(ii)(C) Procedures for monitoring log-in attempts and reporting discrepancies.
  • 164.308(a)(5)(ii)(D) Procedures for creating, changing, and safeguarding passwords.
  • 164.308(a)(6)(ii) Identify and respond to suspected or known security incidents; mitigate, to the extent practicable, harmful effects of security incidents that are known to the covered entity; and document security incidents and their outcomes.
  • 164.308(a)(7)(ii)(A) Establish and implement procedures to create and maintain retrievable exact copies of electronic protected health information.
  • 164.308(a)(7)(ii)(B) Establish (and implement as needed) procedures to restore any loss of data.
  • 164.308(a)(7)(ii)(C) Establish (and implement as needed) procedures to enable continuation of critical business processes for protection of the security of electronic protected health information while operating in emergency mode.
  • 164.308(a)(7)(ii)(D) Implement procedures for periodic testing and revision of contingency plans.
  • 164.308(a)(7)(ii)(E) Assess the relative criticality of specific applications and data in support of other contingency plan components.
  • 164.308(a)(8) Perform a periodic technical and nontechnical evaluation, based initially upon the standards implemented under this rule and subsequently, in response to environmental or operations changes affecting the security of electronic protected health information, that establishes the extent to which an entity’s security policies and procedures meet the requirements of this subpart [the Security Rule].
  • 164.308(b)(4) Document the satisfactory assurances required by paragraph (b)(1) [the Business Associate Contracts and Other Arrangements] of this section through a written contract or other arrangement with the business associate that meets the applicable requirements of §164.314(a) [the Organizational Requirements].

Organizational Requirements

  • 164.314(a)(2)(i) Business associate contract must meet certain requirements.
  • 164.314(a)(2)(ii) Applies to government organizations only.
  • 164.314(b)(1) n/a
  • 164.316(a) Implement reasonable and appropriate policies and procedures to comply with the standards, implementation specifications, or other requirements of this subpart, taking into account those factors specified in 164.306(b)(2)(i), (ii), (iii), and (iv) [the Security Standards: General Rules, Flexibility of Approach]. This standard is not to be construed to permit or excuse an action that violates any other standard, implementation specification, or other requirements of this subpart. A covered entity may change
  • 164.316(b)(1)(i) Maintain the policies and procedures implemented to comply with this subpart in written (which may be electronic) form; and (ii) if an action, activity or assessment is required by this subpart to be documented, maintain a written (which may be electronic) record of the action, activity, or assessment.
  • 164.316(b)(2)(i) Retain the documentation required by paragraph (b)(1) of this section for 6 years from the date of its creation or the date when it last was in effect, whichever is later.
  • 164.316(b)(2)(ii) Make documentation available to those persons responsible for implementing the procedures to which the documentation pertains.
  • 164.316(b)(2)(iii) Review documentation periodically, and update as needed, in response to environmental or operational changes affecting the security of the electronic protected health information.

Physical Safeguards

  • 164.310(a)(2)(i) Establish (and implement as needed) procedures that allow facility access in support of restoration of lost data under the disaster recovery plan and emergency mode operations plan in the event of an emergency.
  • 164.310(a)(2)(ii) Implement policies and procedures to safeguard the facility and the equipment therein from unauthorized physical access, tampering, and theft.
  • 164.310(a)(2)(iii) Implement procedures to control and validate a person’s access to facilities based on their role or function, including visitor control, and control of access to software programs for testing and revision.
  • 164.310(a)(2)(iv) Implement policies and procedures to document repairs and modifications to the physical components of a facility which are related to security (for example, hardware, walls, doors and locks).
  • 164.310(b) Implement policies and procedures that specify the proper functions to be performed, the manner in which those functions are to be performed, and the physical attributes of the surroundings of a specific workstation or class of workstation that can access electronic protected health information.
  • 164.310(c) Implement physical safeguards for all workstations that access electronic protected health information, to restrict access to authorized users.
  • 164.310(d)(2)(i) Implement policies and procedures to address the final disposition of electronic protected health information, and/or the hardware or electronic media on which it is stored.
  • 164.310(d)(2)(ii) Implement procedures for removal of electronic protected health information from electronic media before the media are made available for re-use.
  • 164.310(d)(2)(iii) Maintain a record of the movements of hardware and electronic media and any person responsible therefore.
  • 164.310(d)(2)(iv) Create a retrievable, exact copy of electronic protected health information, when needed, before movement of equipment.

Technical Safeguards

  • 164.312(a)(2)(i) Assign a unique name and/or number for identifying and tracking user identity.
  • 164.312(a)(2)(ii) Establish (and implement as needed) procedures for obtaining necessary electronic protected health information during an emergency.
  • 164.312(a)(2)(iii) Implement electronic procedures that terminate an electronic session after a predetermined time of inactivity.
  • 164.312(a)(2)(iv) Implement a mechanism to encrypt and decrypt electronic protected health information.
  • 164.312(b) Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information.
  • 164.312(c)(2) Implement electronic mechanisms to corroborate that electronic protected health information has not been altered or destroyed in an unauthorized manner.
  • 164.312(d) Implement procedures to verify that a person or entity seeking access to electronic protected health information is the one claimed.
  • 164.312(e)(2)(i) Implement security measures to ensure that electronically transmitted electronic protected health information is not improperly modified without detection until disposed of.
  • 164.312(e)(2)(ii) Implement a mechanism to encrypt electronic protected health information whenever deemed appropriate.