What is the difference between a HIPAA Gap Analysis and a HIPAA Risk Analysis? Many organizations use these interchangeably, however, they are not correct in doing so. Don’t make the same mistake.
Office of Civil Rights Requirements
The Office for Civil Rights clearly spelled out the steps and requirements for a HIPAA Security Risk Analysis. As a result, it requires covered entities to conduct an accurate and thorough assessment. It must consider potential risks and vulnerabilities to the confidentiality, integrity and availability of electronic protected health information held by the organization. Furthermore, entities must consider the potential risks, threats and vulnerabilities to all of the covered entities ePHI. This includes all ePHI which is created received, maintained or transmitted, including the source or location of the ePHI
Understanding a HIPAA Gap Analysis
The HIPAA Rule does not require a HIPAA Gap Analysis. The Gap Analysis is usually a limited evaluation of a covered entity or business associate’s organization to reveal whether there are certain policies, controls or safeguards required by the HIPAA. As a result, it is important rules are in place and implemented. The HIPAA Gap analysis should begin with a review of all policies, procedures, processes, practices and systems. It must investigate all facilities that relate to privacy, uses and disclosures of PHI.
Gap Analysis Insufficient for HIPAA Rule
A Gap Analysis does not satisfy the Security Risk Analysis requirement. It does not demonstrate an accurate and thorough analysis. In effect, it must consider all risks, threats and vulnerabilities to all of the ePHI an entity creates, receives, maintains or transmits. Consequently, the gap analysis is not equivalent to the risk analysis as it does not satisfy the rule as specified by 45 C.F.R. §164.308(a)(ii)(A). It is important to note that OCR expects a covered entity to document and implement all of the necessary regulations of the HIPAA Rule to obtain a Compliant rating.
Therefore, it is important to identify your covered entity’s needs and determine whether you require a Gap Analysis or Risk Analysis. Assure that the vendor you engage is qualified to perform the specific type of analysis that you need.
The Privacy Rule standards address the use and disclosure of individuals’ health information—called “protected health information” by organizations subject to the Privacy Rule — called “covered entities,” as well as standards for individuals’ privacy rights to understand and control how their health information is used.
Death of Celebrities and HIPAA
With the recent deaths of several celebrity musicians, media outlets have an ever-growing source of news and information; some of which is dug up in less than lawful ways. Unfortunately this media creates HIPAA breaches.
HIPAA Cases In Point
The UCLA Medical Center recently had to pay $865,500 in fines for the negligence of patient (mostly celebrity) health information. These breaches constitute a serious risk for hospitals and health centers because the information leaks are often times easily traceable. The demand for media to obtain this information, even through breaches, is high considering the public craves information on the lives of their favorite celebrities but the repercussions can be great.
Employees can be surprisingly negligent with celebrities’ sensitive information. Workers have caused breaches at major hospitals. Cedars-Sinai Hospital in Los Angeles fired five employees and a student assistant in 2013. The hospital traced a breach of Kim Kardashian’s pregnancy information back to them.
Prince’s Medical Information Leak
This issue becomes relevant today considering the recent passing of Prince in April. His health was relatively fine before, and his death came as a shock to many. His death was a great mystery too many. TMZ reported Prince’s medical condition before any official public health announcements. Once again media creates HIPAA breaches.
HIPAA does not apply to TMZ. An employee of the hospital leaked the information. Consequently, the hospital is responsible for a breach of private information.
Just recently it was released that Prince died of a drug overdose but sensitive information can easily be leaked and create legal issues for health providers, especially when it makes its rounds in the news.
HIPAA Breaches Result From Media Coverage
While the demand for information and gossip on celebrities is high and can cloud better judgment, celebrities have the same rights as the rest of us under HIPAA. It is important to restrict media access to a hospital or health center and to inform employees of the legal ramifications of a HIPAA breach. Training employees is crucial and HIPAA Associates can make it easier for you through our expertise on HIPAA compliance and training.
Keep your team informed on standards of HIPAA — Contact HIPAA Associates today for your HIPAA training.
If there is a risk of harm to themselves or others, or if exhibiting behavior that may threaten their health or safety, providers need to be able to use professional judgment. As a result they can identify the potential or likely risk and determine who can help lessen it.
Ways to Share Mental Health Information
There are several ways the provider may address the situation.
If the patient lacks ability to make decisions or is unconscious, the provider can share information with the patient’s personal representative (if applicable). They can also share with family or friends involved in their care if it’s determined in the patients’ best interest.
A provider may contact anyone reasonably able to lessen the risk of harm. This is important when they believe that a patient presents a serious and imminent threat to the health or safety to themselves or another person.
OCR Wont’t Second Guess
The Office for Civil Rights (OCR)states it won’t second guess mental health provider’s judgement when a patient is a threat to himself or others. HIPAA allows mental health providers to share information.
For more detail see the OCR guidance on this vital topic. Remember to check state law for any restrictions on sharing. It is the responsibility of all providers of mental health treatment to know the rules before managing this information.
This is your HIPAA ABCs brought to you by HIPAA Associates. Contact us for more information on this important topic and HIPAA training for you and your company.
HIPAA technical safeguards protect PHI and have become a major part of any HIPAA Privacy program. They are key elements that help to maintain the safety of ePHI as the internet changes. Consequently technical safeguards are important due to technology advancements in the health care industry. The challenge of healthcare organizations is that of protecting electronic protected health information (EPHI). Most importantly, this includes items such as electronic health records, from various internal and external risks.
Comply with Technical Safeguards
The Security Rule, requires a covered entity to comply with the HIPAA Technical Safeguard standards and certain implementation specifications. A covered entity may use any security measures that allow it to reasonably and appropriately do so.
Define “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.” Consequently, this rule is based on several fundamental concepts. These are flexibility, scalability and technology neutrality. Therefore, no specific requirements for types of technology to implement are identified.
Implementing “The Security Rule”
The Rule allows the use of security measures. Consequently, these allows it to reasonably and appropriately implement the standards and implementation specifications. Because of this the covered entity must determine which security measures and specific technologies are reasonable and appropriate for implementation in its organization. There are a variety of measures which can assist an organization to meet these standards. A more detailed description can be found at the HIPAA Security Series published by HHS.gov.
HIPAA technical safeguards are important due to technology advancements. The take away is that Technical Safeguards protect PHI. It is important for all covered entities and business associates who deal with electronic PHI to review their use of Technical Safeguards to be fully in compliance. Feel free to contact us for more guidance on this important topic.
New HIPAA Penalties are now available from the Department of Health and Human Services after it published a notice on April 30th. HHS is exercising its discretion in how it applies its regulations on the assessment of Civil Monetary Penalties (CMPs) under HIPAA. Currently HHS applied the same cumulative annual limit to the four categories of violations.
Pending further rule making HHS will now apply different cumulative annual CMP limits. This will be instead of the maximum $1.5 million for each level of violation. This is a reduction in the maximum limit, scaling down based on the level of culpability. Consequently HHS will use the new penalty structure until further notice. It is important to understand the new HIPAA Penalties from HHS.
Based on four categories of culpability HHS has provided covered entities and business associates with a whole new structure for penalties. In mostcases the amount of penalty will be significantly less than what we have experienced in the past.
For a category of no knowledge the minimum penalty is now $100, and the annual limit will be $25,000 down from $1.5 million.
For a reasonable cause $1,000 is the minimum and $100,000 for an annual limit down from $1.5 million.
Next, willful neglect with a correction it would be $10,000 as a minimum and $250,000 for annual limit.
Finally the highest is for Willful neglect with no correction with $50,000 as a minimum with an annual limit of $1,500,000.
This new guidance changes significantly the penalty structure for HIPAA violations and must be considered and understood by covered entities and business associates who deal with protected health information.
To read this important notice on new HIPAA Penalties from HHS, visit the Federal Register using the link below.
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, provides 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.
Safeguards for Verbal PHI
Apply Reasonable Safeguards for PHI to all of your verbal disclosures of Protected Health Information. When you work with a patient, first determine who is with the patient before discussing PHI. Secondly do not assume the patient permits disclosure of their PHI just because family or a friend is in the room with them. Ask who is with the patient and if the patient permits disclosure. Finally you may ask the persons to leave the room providing the patient an opportunity to object.
In addition, reasonable safeguards for PHI must apply to the use of all paper products to prevent these from reaching the wrong person. Providers must dispose of all paper products that have PHI in a shredder once no longer used. Personnel must make every effort to give the patients summary to the correct patient. When a paper patient summary is given to a patient, every effort must be made to give it to the correct patient.
Password protect all computers in order to protect electronic PHI. Employees must only use the computer medical accounts to which they are assigned. One must consider the use of encryption of any email or texts that contains ePHI.
Use of Reasonable Safeguards for PHI Prevent Violations
In conclusion the use of reasonable safeguards may be the difference between an Office for Civil Rights finding of a privacy violation or a finding that an incidental disclosure occurred. The latter is secondary to a permissible disclosure, and not a violation. Reasonable safeguards protect PHI and help prevent you from violating patient privacy.
The decision to use encryption of ePHI as a safeguard depends on several factors. The HIPAA Security Rule allows safeguarded electronic PHI transmission. After a careful analysis of their system, an organization may decide that Encryption of ePHI as a safeguard is in their best interest. The healthcare provider may then decide to use encryption as the means of protection of sensitive ePHI.
They defined the encryption standard as an addressable requirement and can be confusing. Consequently, if it is a reasonable and appropriate safeguard for the protection of ePHI it should be implemented. The entity may determine it is the best safeguard in its risk management of the confidentiality integrity and availability of ePHI. Consequently, an organization should consider the use of this and implement it in its management of ePHI. Eventually, the entity must document this in the plan.
No Specific Requirements
When they enacted the Security Rule 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.
Alternative to Encryption
Based on its security risk assessment a health care provider may determine that encryption isn’t reasonable and appropriate. They may then present their alternative to protect ePHI. They may also decide to do neither and determine the standard may otherwise be met. The provider should document its reasons for its decision.
Sometimes it is hard to determine under what circumstances PHI disclosure to law enforcement is permissible. For example, HIPAA permits disclosures to law enforcement in certain situations. It is reasonable to disclose if a signed authorization from the patient or their legal representative exists .
When to Respond
The HIPAA Rule permits disclosures when required by law. This may be necessary to respond to subpoena’s and court orders with specific requirements. In addition this may be necessary to investigate a crime, to locate a missing person and to prevent serious threats to public health and safety. State law requires reporting for reports of child and adult abuse and neglect, and to report certain injury and disease.
Besides considering the federal HIPAA law, review state law because it may be more protective than HIPAA. If that is the case the entity must follow state law. It is important for your organization to know what are the permissible disclosures to law enforcement.
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A covered entity must have a procedure for filing a HIPAA privacy complaint by individuals regarding its privacy practices or for an alleged violation of the Privacy Rule. Most importantly the Notice of Privacy Practices must contain contact information for the covered entity’s privacy officer and information on how to submit a complaint to the Office for Civil Rights. In addition, an organization must file complaints within 180 days of when you knew the violation occurred.
The privacy officer or designee investigates all complaints involving privacy of protected health information. The organization should maintain records on the complaints and their resolution. The Privacy Officer will determine whether or not there has been a violation or a breach of unsecured PHI. In a filing to the OCR, there should be information about the complainant. There should be details of the complaint and any additional information that might help OCR when reviewing the complaint.
On behalf of the covered entity, the Privacy Officer will respond to inquiries initiated by the Office for Civll Rights as it investigates complaints.
No Retaliation for Filing a Privacy Complaint
Above all an organization must not retaliate for filing a HIPAA privacy complaint under the HIPAA rules. Most importantly, an organization must encourage employees to file a complaint if they feel a violation took place. Finally, an organization must resolve and prevent them from happening again which helps protect the organization. On the other hand, an employee may complain directly to the OCR if retaliatory action occurred.
In conclusion there must be a good process for filing a privacy complaint and there should be not retaliation for doing so.
This is your HIPAA ABCs brought to you by HIPAA Associates. Contact us for more information on this important topic.
Many breaches of Protected Health Information are a serious matter. A breach is an impermissible use or disclosure of protected health information or PHI. Consequently, it compromises privacy or security of PHI. An organization may presume it is a breach unless certain criteria are met. The covered entity or business associate must demonstrate there is a low probability that the phi has been compromised based on a risk assessment of the following:
Firstly, the nature and extent of the PHI involved, including the types of identifiers and the likelihood of identification
Secondly, the unauthorized person to whom the disclosure was made.
Third, whether the PHI was acquired or viewed.
Finally, the extent to which the risk to the patient was mitigated.
There are many forms of Breaches of Protected Health Information. Some examples of breaches of paper phi are loss of paper files, unsecure disposal, and paperwork given to the wrong person. As a result, all entities that handle paper PHI must be aware of how important it is when sharing or disposing of this information. It is not uncommon for patients to receive the discharge summary of other patients or to see old medical records simply thrown away in the trash.
Examples of electronic PHI breaches include loss of an unencrypted mobile device and sharing PHI on an unsecured document sharing internet site. Most importantly, all organizations must create a process by which electronic PHI is protected on the cloud. Consequently all of these have been the subject of Office for Civil Rights penalties.
Verbal breaches of PHI occur if PHI is disclosed to the wrong individual or if its overheard when safeguards are not used.
It is important for all covered entities and business associates to review their policies. As A result they will be able to better protect PHI whether it is paper, electronic or spoken.
If you are aware of a breach within your organization there are specific steps that must be taken to properly report these. Firs, a breach analysis must be carefully performed. HIPAA Associates works with clients on the breach analysis to determine if they are dealing with a breach of unsecured PHI.
For incidents that are reportable breaches there are steps and deadlines that one must follow for compliant reporting to the individual and to the Office for Civil Rights. Furthermore, we will assist you throughout the process from start to finish on all aspects including mitigation of damages, creating a corrective action plan, drafting notice letters and reporting to the OCR.
Please contact us, for more information about breaches or about HIPAA. Our HIPAA Compliance Plans will help you in preparing for eventual breaches.