It is an understatement to say that Healthcare has experienced a massive amount of change over the past several years. One thing is for certain the environment for exposure to risk for a covered healthcare entity is rising with the changes occurring. That is why recent legislation has been reinforcing and expanding the requirements previously adopted in the HIPAA Security Rule.
Each HIPAA Security Rule standard is required. A covered entity is required to comply with all standards of the Security Rule with respect to all EPHI. 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 a particular standard. Implementation specifications are either required or addressable. However, regardless of whether a standard includes implementation specifications, covered entities must comply with each standard. Documentation is vital!
Some frequently asked Questions:
Doesn’t my EMR/EHR, Practice Management vendor handle all of this for me?
Your certified software vendors are a part of the process, but they are not able to address your business policies and written procedures for how you as a practice handle the information created in the systems. While they are focused on providing the secure frameworks inside their software systems to protect the information, your administrative and physical requirements need to be documented for your practice.
Doesn’t my HIPAA Consent form cover me?
This covers the communication of information and is vital to your business. However you must have documented internal policies and procedures that are routinely communicated for your staff to ensure that the consent information agreed upon by patient and provider is executed.
Doesn’t my outsourced IT support vendor have this all covered for me?
Your vendors are a part of the process, but they are not able to address your business policies and written procedures for how you as a practice handle the information created in the systems. It is vital that you clearly define the roles and responsibilities being delivered by your vendors in your business associate agreements.
Never been an issue before why should I be concerned?
Reputation of your brand has been built with years of hard work. That can all be removed with one incident. How would a breach incident affect your relationship with colleagues and referrals? Everything is affected and almost always never forgiven.
In working with covered entity clients and their business associates, who are also subject to the HIPAA Privacy and Security Rules, it is evident that there is a lot of misunderstanding about which standards and specifications must be implemented to comply with HIPAA. This snapshot is an excerpt from the CMS web site that clarifies the requirements. Some phrases and sentences are bolded for emphasis. Now that the HIPAA Omnibus Final Rule has been published, clearly business associates must implement all the same requirements as covered entities.
“To understand the requirements of the Security Rule, it is helpful to be familiar with the basic concepts that comprise the security standards and implementation specifications. The Security Rule is divided into six main sections – each representing a set of standards and implementation specifications that must be addressed by all covered entities. Each Security Rule standard is a requirement: a covered entity must comply with all of the standards of the Security Rule with respect to the EPHI it creates, transmits or maintains.
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 a particular standard. Implementation specifications are either required or addressable.
- A required implementation specification is similar to a standard, in that a covered entity must comply with it. For example, all covered entities including small providers must conduct a “Risk Analysis” in accordance with Section 164.308(a)(1) of the Security Rule.
- For addressable implementation specifications, covered entities must perform an assessment to determine whether the specification is a reasonable and appropriate safeguard in the covered entity’s environment. After performing the assessment, a covered entity decides if it will implement the addressable implementation specification; implement an equivalent alternative measure that allows the entity to comply with the standard; or not implement the addressable specification or any alternative measures, if equivalent measures are not reasonable and appropriate within its environment.
Covered entities are required to document these assessments and all decisions. For example, all covered entities including small providers must determine whether “Encryption and Decryption” is reasonable and appropriate for their environment in accordance with Section 164.312(a)(1) of the Security Rule.
- Factors that determine what is “reasonable” and “appropriate” include cost, size, technical infrastructure and resources. While cost is one factor entities must consider in determining whether to implement a particular security measure, some appropriate measure must be implemented.
An addressable implementation specification is not optional, and the potential cost of implementing a particular security measure does not free covered entities from meeting the requirements identified in the rule.
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