Suze Shaffer is the owner and president of Aris Medical Solutions. She specializes in HIPAA compliance, risk management, and cyber security. She believes that by educating her clients in understanding why and what needs to be done to protect their practice they have a better outcome.
Suze has been instrumental in helping clients nationwide with risk management, implementing privacy and security rule policies and procedures, and ultimately protecting patient data. She includes state and federal regulatory requirements to ensure clients are protected in all areas.
She has spoken at numerous conferences and functions. She continues to educate organizations how to minimize the risks of data breaches. HIPAA compliance is not an option, it is mandatory for every organization that comes in contact with protected health information to have reasonable and appropriate security measures in place. Unfortunately, most organizations don’t realize they are not compliant until they suffer a data breach or they are faced with an audit or investigation.
Did you know that the Office for Civil Rights (OCR) is the agency that investigates data breaches? Have you seen the heavy fines that have been imposed for non-compliance?
All 50 states now have their own set of privacy laws and the State's Attorney General may also investigate privacy violations!
Do you have all your HIPAA policies and procedures?
Have your employees completed HIPAA training?
Do you have all your Business Associate agreements in place?
If you are unsure about any of these questions, you may be exposed to potential fines by the Office of Civil Rights (OCR) should you become part of a HIPAA complaint or investigation by a disgruntled employee or patient.
Our online HIPAA Keeper™ is designed to educate and protect covered entities such as medical practices, dental practices, and chiropractors. We also have a system just for business associates. How does it work? Just sign-up, enter your employee and business associate information, answer a comprehensive questionnaire, then implement, generate, and download all your documents required under HIPAA law in one easy ZIP file each year. You are required by law to keep your documents for 6 years. Our document package includes employee confidentiality agreements and business associate agreements signed via DocuSign, or you may upload your own. The package also includes a risk management plan, certificates of completion for employee training, as well as all policies and procedures required for HIPAA compliance. There is no better or easier way to document and maintain your HIPAA Compliance history.
To find out more about how our online HIPAA Keeper™ can help your organization with HIPAA Compliance click here:
We try to share useful information as we come across it. Below are some links that we think may be of interest to our audience such as: ICD-10 updates, Fraud, Waste, and Abuse Training, Booklets, and Prevention. We have also included some videos from YouTube. Be sure to follow the guidelines set forth and do not let hindsight get you in trouble.
The OCR released their Summer 2021 Cybersecurity Newsletter and it stated that a recent report of security incidents and data breaches were committed 61% by external actors and 39% by insiders. During COVID last year, systems that monitor audit logs found that internal snooping was up by 90%.
The Information Access Management 45 CFR § 164.308(a)(4)(i) and Access Control 45 CFR § 164.312(a)(1) are two of the HIPAA Security Rule standards that cover access to ePHI.
We will discuss Information Access Management under the Administrative Safeguards first. This standard requires covered entities and business associates to implement policies and procedures that outline how covered entities and business associates authorize or grant access to ePHI within their organization. This may include how access to information systems containing ePHI is requested, authorized, and granted, who is responsible for authorizing access requests, and the requirements for granting access. These policies typically cover workforce roles that may be granted access to particular systems, applications, and/or data. It is important to point out that access must be based on job function or business necessity. Since this is an Addressable standard, if a particular implementation specification is not reasonable and appropriate, entities must document why, and implement equivalent alternative measures if reasonable and appropriate.
Access Establishment and Modification 45 CFR § 164.308(a)(4)(ii)(C) policies describe how to establish, document, review, and modify a user’s access to workstations, transactions, programs, or processes. For example, a workforce member being promoted or given some change in responsibility may require increased access to certain systems and decreased access to others. Another example is that a covered organization could change its system access requirements to permit remote access to systems containing ePHI during a pandemic. Policies and procedures should cover situations such as these to ensure that each workforce member’s access continues to be appropriate for their role.
Access Control under the Technical safeguards is a required standard for covered entities and business associates to implement access controls for electronic information systems to allow access to ePHI only to those approved in accordance with the organization’s Information Access Management process. The flexible, scalable, and technology-neutral nature of the Security Rule permits organizations to consider various access control mechanisms to prevent unauthorized access to ePHI. Such access controls could include role-based access, user-based access, attribute-based access, or any other access control mechanisms the organization deems appropriate. This means, what may be acceptable for one organization may not be suitable for another. Access controls need not be limited to computer systems. Firewalls, network segmentation, and network access control (NAC) solutions can also be effective means of limiting access to electronic information systems containing ePHI. Properly implemented, network-based solutions can limit the ability of a hacker to gain access to an organization’s network or impede the ability of a hacker already in the network from accessing other information systems – especially systems containing sensitive data.
The Access Control standard includes Unique User Identification 45 CFR § 164.312(a)(2)(i) which is a required implementation specification and is a key security requirement for any system. While the use of shared or generic usernames and passwords may seem to provide some short-term convenience, it severely degrades the integrity of a system because it removes accountability from individual users and makes it much easier for the system to become compromised. If information is improperly entered, altered, or deleted, whether intentionally or not, it can be very difficult to identify the person responsible (e.g., for training or sanctions) or determine which users may have been the victim of a phishing attack that introduced ransomware into the organization. Additionally, because shared usernames and passwords can become widely known, it may be difficult to know whether the person responsible was an authorized user. A former employee or contractor, a current employee not authorized for access, a friend or family member of an employee, or an outside hacker could be a source of unauthorized access. The inability to identify and track a user’s identity due to the use of shared user IDs can also impede necessary investigations when the shared user ID is used for unauthorized or even criminal activity. For example, a malicious insider could take advantage of known shared user IDs to hide their activities when collecting personal medical and financial information to use for identity theft. In such as case, an organization’s implemented audit controls would document the actions of the shared user ID, thus potentially limiting the organization’s ability to properly identify and track the malicious insider.
The second implementation specification, Emergency Access Procedure 45 CFR § 164.312(a)(2)(ii) is also a required implementation specification. This implementation specification is applicable in situations in which normal procedures for obtaining ePHI may not be available or may be severely limited, such as during power failures or the loss of Internet connectivity. Access controls are still necessary during an emergency, but may be very different from normal operations. For example, due to the recent COVID-19 public health emergency, many organizations quickly implemented mass telehealth policies. How workforce members can securely access ePHI during periods of increased teleworking should be part of an organization’s Emergency Access Procedures. Appropriate procedures should be established beforehand for how to access needed ePHI during an emergency.
The third implementation specification, Automatic Logoff 45 CFR § 164.312(a)(2)(iii), is an addressable implementation specification. Users sometimes inadvertently leave workstations unattended for various reasons. In an emergency setting, a user may not have time to manually log out of a system. Implementing a mechanism to automatically terminate an electronic session after a period of inactivity reduces the risk of unauthorized access when a user forgets or is unable to terminate their session. Failure to implement automatic logoff not only increases the risk of unauthorized access and potential alteration or destruction of ePHI, it also impedes an organization’s ability to properly investigate such unauthorized access because it would appear to originate from an authorized user.
The final implementation specification is Encryption and Decryption 45 CFR § 164.312(a)(2)(iv), which is also an addressable implementation specification. This technical safeguard can reduce the risks and costs of unauthorized access to ePHI. For example, if a hacker gains access to unsecured ePHI on a network server or if a device containing unsecured ePHI is stolen, a breach of PHI will be presumed and reportable under the Breach Notification Rule (unless the presumption can be rebutted in accordance with the breach risk assessment. The Breach Notification Rule applies to unsecured PHI which is PHI “that is not rendered unusable, unreadable, or indecipherable to unauthorized persons through the use of a technology or methodology specified by the Secretary in the guidance issued under [the HITECH Act].” OCR’s Guidance to Render Unsecured Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals, which provides guidance for securing PHI, states that ePHI that is “at-rest” (i.e., stored in an information system or electronic media) is considered secured if it is encrypted in a manner consistent with NIST Special Publication 800-111 (Guide to Storage Encryption Technologies for End User Devices) (SP 800-111).
EPHI encrypted in a manner consistent with SP 800-111 is not considered unsecured PHI and therefore is not subject to the Breach Notification Rule. Encrypting ePHI in this manner is an excellent example of how implementing an effective encryption solution may not only fulfill an organization’s encryption obligation under the Access Control standard, but also provides a means to leverage the Breach Notification Rule’s safe-harbor provision.
As the use of mobile computing devices (e.g., laptops, smartphones, tablets) becomes more and more pervasive, the risks to sensitive data stored on such devices also increases. Many mobile devices include encryption capabilities to protect sensitive data. Once enabled, a device’s encryption solution can protect stored sensitive data, including ePHI, from unauthorized access in the event the device is lost or stolen.
If you need assistance with HIPAA Risk Management, or guidance with your HIPAA Compliance contact us at 877.659.2467 or complete the contact us form.
“Simplifying HIPAA through Partnership, Education, and Support”
As all of you know, HIPAA is a moving target. Just when you think you understand what is going on, it changes.
By now, most of you have heard about the 21st Century Cures Act / Information Blocking Rule. This final rule will apply to most everyone in healthcare, with variable responsibilities. Healthcare developers, health information exchanges, and health information networks could face civil monetary penalties of up to $1,000,000.00 per violation. Complaints and investigations will be conducted by ONC (Office of the National Coordinator). Healthcare providers could face “appropriate disincentives” that will be established by HHS/CMS but have not been defined yet.
Information blocking can be best described as when EHI (electronic health information) has been requested and denied. I am not going to go into detail on the developers or information exchange side in this notification, but here are a few examples for healthcare providers:
Healthcare organization or hospital refusing to exchange information
Requiring a patient to sign a consent to exchange their information for treatment
Charging a patient for electronic access to their information
Delayed access to information when the information was available days before
When we speak of access or exchange of EHI, that does not mean share everything you have. This is based on the “request”. You will only be obligated to share what is requested. Remember the “minimum necessary” rule, these are similar guidelines.
This is a very complex rule, and more information can be found at:
The proposed changes to the HIPAA Privacy Rule include strengthening patients’ rights to access their own health information, including electronic information; improving information sharing for care coordination and case management for individuals; facilitating greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises; enhancing flexibilities for disclosures in emergency or threatening circumstances; and reducing administrative burdens on HIPAA covered health care providers and health plans, while continuing to protect individuals’ health information privacy interests.
Summary of Major Provisions
HHS proposes to modify the Privacy Rule to increase permissible disclosures of PHI and to improve care coordination and case management by:
Adding definitions for the terms electronic health record (EHR) and personal health application.
Modifying provisions on the individuals’ rightof access to PHI by:
○ Strengthening patients’ rights to inspect their protected health information (PHI) in person. Permitting individuals to take notes or use other personal resources to view and capture images of their PHI.
○ shortening covered entities’ required response time to no later than 15 calendar days (from the current 30 days) with the opportunity for an extension of no more than 15 calendar days (from the current 30-day extension)
○ clarifying the form and format required for responding to individuals’ requests for their PHI
○ requiring covered entities to inform individuals that they retain their right to obtain or direct copies of PHI to a third party when a summary of PHI is offered in lieu of a copy
○ reducing the identity verification burden on individuals exercising their access rights
○ creating a pathway for individuals to direct the sharing of PHI in an EHR among covered health care providers and health plans, by requiring covered health care providers and health plans to submit an individual’s access request to another health care provider and to receive back the requested electronic copies of the individual’s PHI in an EHR
○ requiring covered health care providers and health plans to respond to certain records requests received from other covered health care providers and health plans when directed by individuals pursuant to the right of access
○ limiting the individual right of access to direct the transmission of PHI to a third party to electronic copies of PHI in an EHR
○ specifying when electronic PHI (ePHI) must be provided to the individual at no charge
○ amending the permissible fee structure for responding to requests to direct records to a third party; and
○ requiring covered entities to post estimated fee schedules on their websites for access and for disclosures with an individual’s valid authorizationand, upon request, provide individualized estimates of fees for an individual’s request for copies of PHI, and itemized bills for completed requests.
Amending the definition of health care operations to clarify the scope of permitted uses and disclosures for individual-level care coordination and case management that constitute health care operations.
Creating an exception to the “minimum necessary” standard for individual-level care coordination and case management uses and disclosures. The minimum necessary standard generally requires covered entities to limit uses and disclosures of PHI to the minimum necessary needed to accomplish the purpose of each use or disclosure. This proposal would relieve covered entities of the minimum necessary requirement for uses by, disclosures to, or requests by, a health plan or covered health care provider for care coordination and case management activities with respect to an individual, regardless of whether such activities constitute treatment or health care operations.
Clarifying the scope of covered entities’ abilities to disclose PHI to social services agencies, community-based organizations, home and community-based service (HCBS) providers, (7) and other similar third parties that provide health-related services, to facilitate coordination of care and case management for individuals.
Replacing the privacy standard that permits covered entities to make certain uses and disclosures of PHI based on their “professional judgment” with a standard permitting such uses or disclosures based on a covered entity’s good faith belief that the use or disclosure is in the best interests of the individual. The proposed standard is more permissive in that it would presume a covered entity’s good faith, but this presumption could be overcome with evidence of bad faith.
Expanding the ability of covered entities to disclose PHI to avert a threat to health or safety when a harm is “serious and reasonably foreseeable,” instead of the current stricter standard which requires a “serious and imminent” threat to health or safety.
Eliminating the requirement to obtain an individual’s written acknowledgment of receipt of a direct treatment provider’s Notice of Privacy Practices (NPP).
Modifying the content requirements of the NPP to clarify for individuals their rights with respect to their PHI and how to exercise those rights.
Expressly permitting disclosures to Telecommunications Relay Services (TRS) communications assistants for persons who are deaf, hard of hearing, or deaf-blind, or who have a speech disability, and modifying the definition of business associate to exclude TRS providers.
Expanding the Armed Forces permission to use or disclose PHI to all uniformed services, which then would include the U.S. Public Health Service (USPHS) Commissioned Corps and the National Oceanic and Atmospheric Administration (NOAA) Commissioned Corps.
To read more about this proposed rule and to read public comments submitted in response to the Notice of Proposed Rulemaking on Modifications to the HIPAA Privacy Rule:
Most practices seek assistance from one or more businesses to help them with certain functions within their organization. Depending on the type of service they provide, they may be considered a “Business Associate” under the HIPAA guidelines.
So, what defines a business associate § 164.308(b)(1)?
Any person or entity that may encounter ePHI/PHI while providing services to the covered entity. For example, a shredding company, billing company, or an IT company. Even if the IT company is not responsible for the data transmission or storage of ePHI, they are still considered a business associate under the definition by the Office for Civil Rights (OCR). This is because they may have access to computers or software to assist the provider when issues arise, or when updates are needed.
Software providers such as EHR/ EMRs, and practice management are also BAs. Custom software providers may also be included if they maintain the system and are required to provide updates. The exception to this would be if a custom software were developed and turned over to the practice for their use and then maintained by the IT vendor. The IT vendor would be the BA.
Clearinghouses are covered entities, and business associates of a covered entity since they facilitate the processing of health information from a nonstandard format into standard format, or from standard format into nonstandard format.
Some practices with multiple partners may use revenue from patients to determine each provider’s share. If they use a third party like a CPA, then the CPA may be considered a BA.
If an attorney is needed to defend the provider/practice against a patient and PHI is disclosed, the attorney is then a BA.
An easy way to remember this is… if PHI/ePHI is disclosed or the possibility of being disclosed during the job function of the vendor, then they are a BA.
A cleaning company is NOT considered a business associate even though they may encounter PHI because their job function does not include the creation, transmitting, or maintaining of ePHI. It is advisable to require the company to sign a confidentiality agreement and require their employees receive HIPAA training, so they understand the HIPAA rules.
When hiring a business associate it is required under HIPAA to ensure your vendor is HIPAA compliant. The first step is to obtain a Business Associate Agreement (BAA), but you must also have reasonable assurances they are in fact HIPAA compliant. You may request their most recent HIPAA training for the employees that will be responsible for working withing your practice, policies on data security, and depending on the services they provide, a copy of their latest risk analysis (first and last page that demonstrates who conducted the analysis and when). You also have the right to ask if they use business associates (subcontractors). The practice must ensure that anyone and everyone that comes in contact with ePHI/PHI understands how to protect this data.
Large medical practices are targeted by hackers since this information is so valuable. Smaller practices are hacked through phishing attacks, unsuspecting employees, business associates, and outdated software/hardware. It is everyone’s responsibility within the practice to ensure all data is secure and to avoid data breaches. I am sure you are thinking that if the government cannot keep data secure, how can you? Large organizations are always a target, and they have the same issues as smaller ones just more area of vulnerabilities for the bad actors to get in.
Stay safe out on the World Wide Web (WWW), we call it, the Wild Wild West. The biggest difference is, during the Wild Wild West days, you could see trouble coming into town and prepare. On the World Wide Web, trouble is invisible until it is too late.
If you need assistance with Risk Management or guidance with your HIPAA Compliance, contact us at 877.659.2467 or complete the contact us form.
“Simplifying HIPAA through Partnership, Education, and Support”
Many practices think once they have conducted a risk analysis, they are done with their HIPAA compliance efforts. Unfortunately, a risk analysis is just the beginning! You must document your ongoing HIPAA efforts through evaluations.
45 CFR § 164.308(a)(8) Evaluation – HIPAA requires organizations to review technical and non-technical aspects of their compliance efforts based on their original risk analysis. These evaluations could be based on operational or environmental changes that affect the security of ePHI.
Setting a time frame in which to perform your evaluations will be essential in determining if you are adequately protecting ePHI. Organizations may perform these processes annually or as needed (e.g., bi-annual or every 3 years) depending on circumstances of their environment. An annual evaluation is recommended due the ever-changing world of technology. As software/hardware are outdated or replaced, the new devices must be reviewed to ensure they are HIPAA compliant and installed properly. Of course, if you have a major change in your organization or a data breach you may need to reorganize your quarterly plans and conduct a new risk analysis. Keep in mind, should you suffer a data breach and you have not updated your risk analysis and a vulnerability is discovered; you could be heavily fined. It is important to know if the security plans and procedures you have implemented continue to adequately protect ePHI. Some organizations do not understand the need in hiring an IT vendor with the thoughts they can do this themselves. Depending on the services that are being offered, you could be making a huge mistake. An IT vendor that specializes in data security for healthcare is essential in protecting your data and your assets.
We recommend reviewing certain aspects each quarter of each year. For instance, the first quarter review your Risk Management Plan to ensure everything is documented. It may not be necessary to update your Breach Notification Plan, but we suggest reading it to remind yourself what to do in the event of a data breach.
The second quarter would be a good time to review your Contingency Plan and make any updates. You may need to request additional information from your IT department or vendor.
The third quarter review your HIPAA Privacy Rule Policies, Procedures and Documentation. Most of these will not need any updates, but as always, it is recommended to review them, just in case something has changed.
The fourth quarter review your HIPAA Security Rule Policies, Procedures and Documentation. As in the privacy section, you may not need to update very many, but it is required under HIPAA to review them. Pay close attention to the Technical Safeguards section, as this may be where changes need to be made.
We also recommend reviewing your insurance policies and vendor contracts at least 60-90 days before they renew. This should give you ample time to review and decide if you have adequate coverage. This includes medical malpractice, life, and disability for key personnel. We also suggest reviewing your contract with your IT vendor at least 90 days before the contract terminates, some vendors add stipulations in the contract that automatically locks you in an additional year.
Cyber/breach insurance should be reviewed with an agent that specializes in this type of coverage; the average policy may not be enough to protect you.
Aris has been busy creating an automated HIPAA compliance package. With the new program, you will be able to update your plan and your policies quickly and easily. With the documentation within the system, you will be able to demonstrate your on-going HIPAA compliance efforts. Watch for the launch annoucement!
If you need assistance with Risk Management or guidance with your HIPAA Compliance, contact us at 877.659.2467 or complete the contact us form.
“Simplifying HIPAA through Partnership, Education, and Support”
Recently a cosmetic practice was fined $30,000 to settle potential HIPAA Privacy Rule violations. In the past many practices believed if they did not accept insurance payments (considered as a “transaction” under HIPAA), they were immune from the privacy rule. This may not be the case. There is a section in the rule that states “Other transactions that the Secretary may prescribe by regulation”. HIPAA compliance is a balancing act, are you willing to lose $30K of your hard-earned money to test the system?
This investigation started with a compliant from a patient that had requested their medical record and did not receive them in a timely manner. Under the HIPAA Privacy Rule, the provider must respond to a patient’s request for access no later than 30 calendar days after the request. If the covered entity is not able to act within this timeframe, the entity may have up to an additional 30 calendar days if they provide the individual (within the initial 30-day period) with a written statement for the reason of the delay and include a date when the entity will have the information available. See 45 CFR §164.524(b)(2). Unfortunately for this practice, this was not handled in a timely manner. Therefore, an investigation was launched.
Let us review how this happens.
Once a complaint is filed to the Office for Civil Rights (OCR), the OCR will determine if the complaint falls within their duties to investigate. Once an investigation has been opened, the OCR will contact the practice for their documentation surrounding the incident. Depending on the documentation that is submitted will determine if a desk audit is warranted. Therefore, documentation is SO important, you may be able to avoid a desk audit if you supply the appropriate documents.
During a desk audit more than likely, you will be asked for documentation of what preventative measures you had in place before the incident and what you have implemented to prevent this from happening again. While you are being investigated the OCR may also review your compliance in other areas. If they find discrepancies, you could be fined for those as well. HIPAA encompasses a large range of requirements. Patient privacy, patient rights, and data security to name a few. I will not go into detail during this notification since we are sharing the security rule requirements in other messages.
Each resolution agreement that is issued by the HHS/OCR outlines the deficiencies they uncover. Most of them include the lack of a risk analysis, risk management, training, business associate agreements, and policies and procedures. During this investigation, other violations were uncovered and included the social security act was named in the resolution agreement: Section 1128A of the Social Security Act (42 U.S.C. § 1320a- 7a) a.
From this, I hope you can understand the importance of HIPAA compliance. Because one simple oversight can cause this much heartache. Patient privacy, patient rights, and data security is as important as caring for your patients. We have just learned that any entity that has patient data can be investigated and fined for violations under HIPAA.
Tell your friends and colleagues to ensure everyone understands no one is immune from HIPAA if you have patient data. Fines are fierce and not worth taking a chance by thinking “it won’t happen to me”.
If you need assistance with HIPAA Training, Risk Management, or guidance with your HIPAA Compliance contact us at 877.659.2467 or complete the contact us form.
“Simplifying HIPAA through Partnership, Education, and Support”
When it comes to planning for a disaster, most people think “that won’t happen to me”. Under HIPAA, you are required to ensure the integrity, confidentiality, and available of ePHI. When creating your contingency plan, it is necessary to review what natural disasters could happen in your area, how would you handle a hacking incident, and what precautions do you have in place to protect your facility from theft? The idea is to have a “plan” in place for whatever may happen.
The Contingency Plan § 164.308(a)(7) standard has five implementation sections, three are required and two are addressable. Remember, addressable does not mean optional. Addressable gives the entity some flexibility on how to implement the requirements.
164.308(a)(7)(ii)(A) Data Backup Plan (R)
Most covered entities may have backup procedures as part of current business practices. Data backup plans are an important safeguard for all covered entities, and a required implementation specification. “Establish and implement procedures to create and maintain retrievable exact copies of electronic protected health information.”
164.308(a)(7)(ii)(B) Disaster Recovery Plan (R)
When it comes to disaster recovery planning, your plan may differ from others. Be sure your plan is based on where your data is located. Review where your data is located. Is it in a cloud-based or a premise (onsite) system? Although the majority of your ePHI may be in your EHR, you may have certain programs or files that are critical to business continuity that should also be backed up.
“Establish (and implement as needed) procedures to restore any loss of data.” Some organizations may already have a general Disaster Plan that meets this requirement; however, each entity must review the current plan to ensure that it allows them to recover ePHI.
164.308(a)(7)(ii)(C) Emergency Mode Operation Plan (R)
When an organization is operating in emergency mode due to a technical failure or power outage, security processes to protect ePHI must be maintained. “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.”
An emergency mode operation plan should include procedures to enable continued operations in the event of a natural disaster, fire, flood, vandalism, or a system failure while still protecting the facility and the electronic data. This may include budgeting for and scheduling outside resources.
For example:
Does the plan include a list of different types of emergencies and how to react to them?
Would your organization need a temporary location, or would you be able to use one of your other locations?
Does your organization have reasonable arrangements with your IT vendor to ensure critical systems are back up and running in an appropriate time frame?
Has your organization created an emergency process that includes procedures that can be accomplished manually that is critical to patient care and business continuity?
Has your organization secured a contract with a security company to protect the facility in the event of severe damage to the building?
Has your organization considered agreements with suppliers to provide equipment or considered a backup power source?
Has your organization created a budget and allocated for the extra expenses should an emergency arise?
164.308(a)(7)(ii)(D) Testing and Revision Procedures (A)
Where the testing and revision procedures implementation specification is a reasonable and appropriate safeguard the entity must: “Implement procedures for periodic testing and revision of contingency plans.” It is important to point out that this implementation specification applies to all implementation specifications under the Contingency Plan Standard, including the Data Backup Plan, Disaster Recovery Plan, and Emergency Mode Operations Plan.
164.308(a)(7)(ii)(E) Applications and Data Criticality Analysis (A)
“Assess the relative criticality of specific applications and data in support of other contingency plan components.”
This implementation specification requires entities to identify their software applications (data applications that store, maintain or transmit ePHI) and determine how important each is to patient care or business needs, in order to prioritize for Data Backup, Disaster Recovery and/or Emergency Mode Operations Plans. A prioritized list of specific applications and data will help determine which applications or information systems be restored first and/or which must be available at all times.
In our 7 Simple-Steps to HIPAA Compliance package, we have included an outline to assist clients in completing their Contingency Plan. You may also request a plan from your IT vendor to assist you as well. Try to think outside the box to ensure all bases are covered.
If you need assistance with your HIPAA Contingency Plan or guidance with your HIPAA Compliance contact us at 877.659.2467 or complete the contact us form.
“Simplifying HIPAA through Partnership, Education, and Support”
What the Office for Civil Rights (OCR) and the Department of Health and Human Services (HHS) considers as reasonable and appropriate safeguards are always open for discretion. Every organization is different, and what may work for one, may not for another. For that reason, this information is a guideline only and should not be taken as legal advice.
Here are a few areas that should be reviewed:
§ 164.308(a)(5)(i) Security Awareness and Training has (4) implementation standards. They are labeled as “Addressable” under the HIPAA Security Rule. Do not be fooled by the term addressable, that does not mean optional. It just means you have options in implementing the standards.
The Security Awareness and Training standard means that a covered entity must implement a security training program for all employees including management. The frequency in which the training is performed is typically questionable and HIPAA requires new hires must be trained within a reasonable amount of time. We recommend HIPAA training BEFORE any person has access to PHI or ePHI since one mistake can cause a data breach. Then, HIPAA requires “periodic” training. Most organizations conduct annual HIPAA training. Although HHS does not specifically state you must conduct annual training, should you suffer a data breach and it is caused by an employee that did not have proper training, you could be fined for that violation. That is why it is so important to ensure your employees not only attend (and have documentation) HIPAA training, but must also actually understand what is required of them and how to safeguard patient data.
§ 164.308(a)(5)(ii)(A) Security Reminders – HIPAA is not just a once-a-year process. Periodic security reminder updates should be conducted throughout the year to keep HIPAA and data security in the minds of your staff. This should be documented as well.
§ 164.308(a)(5)(ii)(B) Protection from Malicious Code – Procedures must be in place to guard against, detect, and report viruses and malware. Up to date anti-virus and anti-malware software can ward off most intrusions. That is, as long your staff does not click on attachments or visit certain website where malicious code is located. Education is key. Ensuring software patches are applied when released, scanning systems on a routine basis, and utilizing firewalls are also very important. Making sure users do not introduce malicious code from downloads, DVDs, flash-drives, or other products brought from home.
§ 164.308(a)(5)(ii)(C) Log-in Monitoring – Procedures for monitoring log-in activity and reporting discrepancies. This standard states you must monitor user logins and unsuccessful attempts. Best practices are to have procedures to lock a user out after a predetermined number of failed log-in attempts. This may prevent an unauthorized user from gaining access to your system. With malware that repeatedly tries new passwords, this is highly recommended.
§ 164.308(a)(5)(ii)(D) Password Management – Procedures for creating, changing, and safeguarding passwords. All users must use their own credentials to log into systems that contain ePHI. Passwords are to be complex, never shared, secure, and changed at least every 90 days. Although HIPAA does not specifically state the 90-day rule, it is best practices unless you are utilizing a second method of authentication.
§ 164.308(a)(6)(i) Security Incident Procedures has (1) implementation standard, and this is “Required”. This means you MUST implement the standard as stated. You must have policies and procedures in place that identify security incidents, so employees understand what a security incident is, and how to respond.
§ 164.308(a)(6)(ii) Response and Reporting requires a covered entity to have policies and procedures in place to report and mitigate security incidents and determine if a data breach occurred. Then, if a data breach has occurred, the covered entity must determine how many patient records were affected. The time frame to report the breach to OCR and possibly state and local agencies differs on whether the breach is over 500 patient records or not. This should be clearly outlined in your Breach Notification Plan. During the breach notification process, state law will supersede the federal HIPAA law if the state law is more stringent. Keep in mind, all 50 states have their set of privacy laws.
We will be adding more information on other Security Standards, so watch for more posts!
If you need assistance with HIPAA Risk Management or guidance with your HIPAA Compliance contact us at 877.659.2467 or complete the contact us form.
It is hard to believe we are in 2021, but I am sure you are like the rest of us and glad to see 2020 in the rear-view mirror.
As we move into this new year, we need to look ahead and learn from what has happened in the past. Last month we informed you about many HIPAA violations that the Office for Civil Rights (OCR) had investigated. Most of these violations could have been prevented. In fact, I was talking with a colleague that owns an audit log monitoring system and he informed me that during the pandemic they saw a 90% increase in snooping into patient records of the same last name. Fortunately for his clients, this was immediately stopped, and the employee(s) were sanctioned. This made me want to remind you of a few requirements under HIPAA.
164.308(a)(1)(ii)(c) Sanction Policy – is a “required” standard under the HIPAA Security Rule. Employers are required by law to apply sanctions against employees who violate HIPAA, otherwise the employer could be fined.
164.308(a)(1)(ii)(d) Information System Activity Review – is another required standard. Which requires procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports. A security incident can be best described as the attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system.
164.312(b) Audit Controls – is yet another required standard that states you must implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information (ePHI). This standard goes hand in hand with Information System Activity Review.
What does this mean to you?
First, you must understand what is considered “normal” usage within your software/hardware that contains ePHI. Then you must monitor your systems for abnormal behavior. This is a HUGE time-consuming task and unless you are monitoring every employee, 24/7 you may miss something. We highly recommend utilizing a third party to do this for you. The company we work with has interfaces with over 60 EHRs and is fully automated. If they do not have an interface, they will create one, or show you how to upload the logs in a matter of minutes instead of hours. No more looking over lengthy audit log reports. You simply receive an alert when there is abnormal activity. Best of all, this protects your patient data and your practice from fines and penalties. If you would like to learn more about this service, use the contact us page.
If you need assistance with HIPAA Risk Management or guidance with your HIPAA Compliance, contact us at 877.659.2467 or complete the contact us form.
