HIPPA Compliance Certifications

Before discussing the elements of our HIPAA compliance solution, it is best to answer the question “What is HIPAA compliance?” HIPAA compliance involves fulfilling the requirements of the Health Insurance Portability and Accountability Act of 1996, its subsequent amendments, and any related legislation such as the Health Information Technology for Economic and Clinical Health (HITECH) Act.

Typically the question following “What is HIPAA compliance?” is “What are the HIPAA compliance requirements?” That question is not so easy to answer as – in places – the requirements of HIPAA are intentionally vague. This is so HIPAA can be applied equally to every different type of Covered Entity or Business Associate that comes into contact with Protected Health Information (PHI). For the sake of clarification:

What is a Covered Entity?

A covered entity is a health care provider, a health plan or a health care clearing house who, in its normal activities, creates, maintains or transmits PHI. There are exceptions. Most health care providers employed by a hospital are not covered entities. The hospital is the covered entity and responsible for implementing and enforcing HIPAA complaint policies.

Employers – despite maintaining health care information about their employees – are not generally covered entities unless they provide self-insured health cover or benefits such as an Employee Assistance Program (EAP). In these cases they are considered to be “hybrid entities” and any unauthorized disclosure of PHI may still be considered a breach of HIPAA.

What is a Business Associate?

A “business associate” is a person or business that provides a service to – or performs a certain function or activity for – a covered entity when that service, function or activity involves the business associate having access to PHI maintained by the covered entity. Examples of Business Associates include lawyers, accountants, IT contractors, billing companies, cloud storage services, email encryption services, etc.

Before having access to PHI, the Business Associate must sign a Business Associate Agreement with the Covered Entity stating what PHI they can access, how it is to be used, and that it will be returned or destroyed once the task it is needed for is completed. While the PHI is in the Business Associate´s possession, the Business Associate has the same HIPAA compliance obligations as a Covered Entity.

HIPAA Requirements

Despite the intentionally vague HIPAA requirements, every Covered Entity and Business Associate that has access to PHI must ensure the technical, physical and administrative safeguards are in place and adhered to, that they comply with the HIPAA Privacy Rule in order to protect the integrity of PHI, and that – should a breach of PHI occur – they follow the procedure in the HIPAA Breach Notification Rule.

All risk assessments, HIPAA-related policies and reasons why addressable safeguards have not been implemented must be chronicled in case a breach of PHI occurs and an investigation takes place to establish how the breach happened. Each of the HIPAA requirements is explained in further detail below. Business unsure of their obligation to comply with the HIPAA requirements should seek professional advice.

HIPAA Security Rule

The HIPAA Security Rule contains the standards that must be applied to safeguard and protect ePHI when it is at rest and in transit. The rules apply to anybody or any system that has access to confidential patient data. By “access” we mean having the means necessary to read, write, modify or communicate ePHI or personal identifiers which reveal the identity of an individual. There are three parts to the HIPAA Security Rule – technical safeguards, physical safeguards and administrative safeguards – and we will address each of these in order in our HIPAA compliance checklist.

Technical Safeguards

The Technical Safeguards concern the technology that is used to protect ePHI and provide access to the data. The only stipulation is that ePHI – whether at rest or in transit – must be encrypted NIST standards once it travels beyond an organizations internal firewalled servers. This is so that any breach of confidential patient data renders the data unreadable, undecipherable and unusable. Thereafter organizations are free to select whichever mechanisms are most appropriate to:

Implementation Specification	Required or Addressable	Further Information
Implement a means of access control	Required	This not only means assigning a centrally-controlled unique username and PIN code for each user, but also establishing procedures to govern the release or disclosure of ePHI during an emergency.
Introduce a mechanism to authenticate ePHI	Addressable	This mechanism is essential in order to comply with HIPAA regulations as it confirms whether ePHI has been altered or destroyed in an unauthorized manner.
Implement tools for encryption and decryption	Addressable	This guideline relates to the devices used by authorized users, which must have the functionality to encrypt messages when they are sent beyond an internal firewalled server, and decrypt those messages when they are received.
Introduce activity logs and audit controls	Required	The audit controls required under the technical safeguards are there to register attempted access to ePHI and record what is done with that data once it has been accessed.
Facilitate automatic log-off of PCs and devices	Addressable	This function logs authorized personnel off of the device they are using to access or communicate ePHI after a pre-defined period of time. This prevents unauthorized access of ePHI should the device be left unattended.

Physical Safeguards

The Physical Safeguards focus on physical access to ePHI irrespective of its location. ePHI could be stored in a remote data center, in the cloud, or on servers which are located within the premises of the HIPAA covered entity. They also stipulate how workstations and mobile devices should be secured against unauthorized access:

Implementation Specification	Required or Addressable	Further Information
Facility access controls must be implemented	Addressable	Controls who has physical access to the location where ePHI is stored and includes software engineers, cleaners, etc. The procedures must also include safeguards to prevent unauthorized physical access, tampering, and theft.
Policies for the use/positioning of workstations	Required	Policies must be devised and implemented to restrict the use of workstations that have access to ePHI, to specify the protective surrounding of a workstation and govern how functions are to be performed on the workstations.
Policies and procedures for mobile devices	Required	If users are allowed to access ePHI from their mobile devices, policies must be devised and implemented to govern how ePHI is removed from the devices if the user leaves the organization or the device is re-used, sold, etc.
Inventory of hardware	Addressable	An inventory of all hardware must be maintained, together with a record of the movements of each item. A retrievable exact copy of ePHI must be made before any equipment is moved.

Administrative Safeguards

The Administrative Safeguards are the policies and procedures which bring the Privacy Rule and the Security Rule together. They are the pivotal elements of a HIPAA compliance checklist and require that a Security Officer and a Privacy Officer be assigned to put the measures in place to protect ePHI, while they also govern the conduct of the workforce.

The OCR pilot audits identified risk assessments as the major area of Security Rule non-compliance. Risk assessments are going to be checked thoroughly in the second phase of the audits; not just to make sure that the organization in question has conducted one, but to ensure to ensure they are comprehensive and ongoing. A risk assessment is not a one-time requirement, but a regular task necessary to ensure continued compliance.

The administrative safeguards include:

Implementation Specification	Required or Addressable	Further Information
Conducting risk assessments	Required	Among the Security Officer´s main tasks is the compilation of a risk assessment to identify every area in which ePHI is being used, and to determine all of the ways in which breaches of ePHI could occur.
Introducing a risk management policy	Required	The risk assessment must be repeated at regular intervals with measures introduced to reduce the risks to an appropriate level. A sanctions policy for employees who fail to comply with HIPAA regulations must also be introduced.
Training employees to be secure	Addressable	Training schedules must be introduced to raise awareness of the policies and procedures governing access to ePHI and how to identify malicious software attacks and malware. All training must be documented.
Developing a contingency plan	Required	In the event of an emergency, a contingency plan must be ready to enable the continuation of critical business processes while protecting the integrity of ePHI while an organization operates in emergency mode.
Testing of contingency plan	Addressable	The contingency plan must be tested periodically to assess the relative criticality of specific applications. There must also be accessible backups of ePHI and procedures to restore lost data in the event of an emergency.
Restricting third-party access	Required	It is vital to ensure ePHI is not accessed by unauthorized parent organizations and subcontractors, and that Business Associate Agreements are signed with business partners who will have access to ePHI.
Reporting security incidents	Addressable	The reporting of security incidents is different from the Breach Notification Rule (below) inasmuch as incidents can be contained and data retrieved before the incident develops into a breach.

The difference between the “required” safeguards and the “addressable” safeguards on the HIPAA compliance checklist is that “required” safeguards must be implemented whereas there is a certain amount of flexibility with “addressable” safeguards. If it is not reasonable to implement an “addressable” safeguard as it appears on the HIPAA compliance checklist, covered entities have the option of introducing an appropriate alternative, or not introducing the safeguard at all.

That decision will depend on factors such as the entity’s risk analysis, risk mitigation strategy and what other security measures are already in place. The decision must be documented in writing and include the factors that were considered, as well as the results of the risk assessment, on which the decision was based.

 

As you can see, HIPPA compliance is confusing and requires an expert educated in understanding how to implement such safety precautions on your infrastructure and devices.  Stanton PC HIPPA experts are ready to run tests to see if you are complaint and make the recommended strategies to get you there.  The fees are far less then those if you should be found liable due to data theft or hacking which we see everyday in the news.  We can take that concern out of your mind by making your business fully complaint for your patients.  Call us at 714-928-6383 today to schedule a consultation and testing.