The Office for Civil Rights (OCR) released a Request for Information (RFI) seeking comments from all stakeholders including covered entities, business associates, patients, and their families. The growing number of cybersecurity threats are a significant concern driving the need for enhanced safeguards of electronic protected health information (ePHI).
This RFI will enable the OCR to consider ways to support the healthcare industry’s implementation of recognized security practices. The RFI also will help OCR consider ways to share funds collected through enforcement with individuals who are harmed by violations of the HIPAA Rules.
Through today’s RFI, OCR is seeking public comment on the following provisions of law:
Recognized Security Practices. Section 13412 of the HITECH Act requires HHS to take into consideration certain recognized security practices of covered entities (health plans, health care clearinghouses, and most health care providers) and business associates1 when determining potential fines, audit results, or other remedies for resolving potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule pursuant to an investigation, compliance review, or audit. Public Law 116-321 went into effect when it was signed into law on January 5, 2021.
One of the primary goals of this provision is to encourage covered entities and business associates to do “everything in their power to safeguard patient data.”
The RFI solicits comment on how covered entities and business associates are implementing “recognized security practices,” how they anticipate adequately demonstrating that recognized security practices are in place, and any implementation issues they would like OCR to clarify through future guidance or rulemaking.
Civil Money Penalty (CMP) and Settlement Sharing. Section 13410(c)(3) of the HITECH Act requires HHS to establish by regulation a methodology under which an individual harmed by a potential violation of the HIPAA Privacy, Security, and/or Breach Notification Rules may receive a percentage of any CMP or monetary settlement collected with respect to such offense. Section 13140(d)(1) of HITECH requires that OCR base determinations of appropriate penalty amounts on the nature and extent of the violation and the nature and extent of the harm resulting from such violation. The HITECH Act does not define “harm,” nor does it provide direction to aid HHS in defining the term.
The RFI solicits public comment on the types of harms that should be considered in the distribution of CMPs and monetary settlements to harmed individuals, discusses potential methodologies for sharing and distributing monies to harmed individuals, and invites the public to submit alternative methodologies.
OCR encourages comments from all stakeholders, including patients and their families, HIPAA covered entities and their business associates, consumer advocates, health care professional associations, health information management professionals, health information technology vendors, and government entities.
Individuals seeking more information about the RFI or how to provide written or electronic comments to OCR should visit the Federal Register to learn more:
The Office for Civil Rights sent out a cyber newsletter stating that throughout 2020-2021 hackers have targeted the health care industry and the number of breaches increased 45% from 2019 to 2020. The number of breaches due to hacking or IT incidents account for 66% of all breaches affecting over 500 patients records in 2020. Cyber-attacks are critical in health care since it can disrupt services to patients and destroy patient data.
Most cyber-attacks could have been prevented if covered entities and business associates had implemented the HIPAA Security Rule requirements. Technical safeguards are based on the organizations size, type of environment, and how data flows in and out of their systems. Keep in mind, phishing attacks and weak authentication protocols are the most common exploitations.
What can you do to prevent cyber-attacks?
While nothing is 100%, simple precautious can go a long way. Educating your staff should be a top priority. Tricking employees to click on links or to share vital information is the most common tactic. An unsuspecting employee is typically how an attack starts. There are more sophisticated methods that can exploit previously unknown vulnerabilities, but phishing is still the most common. Train your employees not to click on attachments unless they are expecting the communication and the sender has been verified. Also, do not click on links within emails. Best practices are to open your browser window and go to the website and log-in from there. If the employee suspects an email contains a virus or is suspicious, they should contact their IT department/vendor and verify. It is always better to be safe than sorry later!
Ongoing HIPAA training is essential to keep up with new threats. Annual training keeps HIPAA on the minds of your employees, but when you add monthly security reminders it helps so much more! The HIPAA security officer should share emails or website information from reliable sources to keep their employees informed. When you receive Aris’ monthly Security Newsletter, share this valuable information with the staff, including clinicians, and management since they are often a target from hackers. If possible, utilize a company that offers Phishing training and exercises. Contact us for some suggestions.
Unfortunately, security training cannot be effective if it is viewed by as a burdensome, and employees just want to “check-the-box”. Keep staff members engaged by explaining cyber security is everyone’s job in protecting ePHI.
In addition to education, organizations can mitigate the risk of phishing attacks by implementing anti-phishing technologies. You should talk to your IT vendor about what type of services they have that can help you. For example, if an email is suspected of being a threat, it can be blocked, and appropriate personnel notified. Another approach can involve scanning web links or attachments included in emails for potential threats and removing them if a threat is detected. Newer techniques can leverage machine learning or behavioral analysis to detect potential threats and block them as appropriate. Many available technology solutions use a combination of these approaches. Implementing access controls that restrict access to ePHI to only those requiring such access is also a requirement of the HIPAA Security Rule. Organizations may determine that because its privileged accounts (administrator) have access that supersedes other access controls (role or user-based access) and thus can access ePHI, the privileged accounts present a higher risk of unauthorized access to ePHI than non-privileged accounts. If exploited through an administrative access point, not only could privileged accounts supersede access restrictions, but they could also delete ePHI or even alter or delete hardware or software configurations, rendering devices inoperable. To reduce the risk of unauthorized access to privileged accounts, the organization could decide that a privileged access management (PAM) system is reasonable and appropriate to implement.
Covered entities and business associates are required under HIPAA to ensure the integrity, confidentiality, and availability of ePHI. This means protecting patient data from improper alteration, destruction, and making sure it is available when needed. Hackers that penetrate an organization’s network can wreak havoc by encrypting patient data, modifying data, or stealing the data. Based on the type of network your organization utilizes, you may need domain controller and/or business grade firewall. Some firewalls that are designed for “small” businesses, are not robust enough for healthcare. As devices age, they must be replaced since technology is always changing, and vulnerabilities are exploited. Before purchasing new equipment, it is suggested to consult with an IT vendor that specializes in healthcare. It is important to ensure the device can be used in a healthcare setting, set up correctly, and custom security policies implemented.
As we just mentioned about devices being upgraded, so must software applications. Again, when an organization utilizes outdated software, these can be exploited as well. I have heard over the years many different reasons why “programs” cannot be upgraded, it won’t work with the new version of windows, they don’t offer upgrades, or simply they do not want to spend the money. None of these reasons are acceptable excuses from the Office for Civil Rights unless you have security measures in place to protect the legacy systems and they are safe from the “outside” world. If you utilize outdated equipment or software and you are hacked, you CAN and WILL be fined if you have not demonstrated best practices in protecting your data. You literally are running the risk of losing your business. The fines are THAT much!
We recommend yearly network security audits that are performed by a network security company. This is different that your regular IT company that maintains your systems unless they truly specialize in network security. This type of company should perform several types of vulnerability scans. Not all scans are created equal and different types may be necessary to uncover holes in your security. For example, scans that look for weak passwords, duplicate passwords, weak access controls, and vulnerable ports. 80% of the attacks can be linked to weak authentication credentials. By adding a second authentication process, a bio-scanner, or RFID card to access ePHI greatly enhances security. This is especially helpful for those using remote access. When it comes to your daily IT vendor, they must also under HIPAA and follow the security protocols set forth by NIST. Several medical practices have been breached due to incorrect settings within the network. Some of these breaches cost $3M in fines!
Although malicious attacks targeting the health care sector continue to increase, many of these attacks can be prevented or mitigated by fully implementing the Security Rule’s requirements. Many organizations continue to underappreciate the risks and vulnerabilities of their actions or inaction (increased risk of remote access, unpatched or unsupported systems, not fully engaging the workforce in cyber defense).
Unfortunately, there isn’t a single magic action to ensure the safety of your data, it is a combination of the above and ongoing upgrades.
To find out more about how our online HIPAA Keeper™ can help your organization with HIPAA Compliance click here:
This week the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced the resolution of four investigations related to the HIPAA privacy rule.
Two cases were part of the HIPAA Right of Access, bringing the total number of enforcement actions to twenty-seven since the initiative began. Another case included misuse of social media in response to a negative review.
A solo dental practitioner in Butler, Pennsylvania, failed to provide a patient with a copy of their medical record. After being issued a Notice of Proposed Determination, the doctor requested a hearing before an Administrative Law Judge. The litigation was resolved before the court made a determination by a settlement agreement in which the doctor agreed to pay $30,000 and take corrective actions to comply with the HIPAA Privacy Rule’s right of access standard.
A dental practice with offices in Charlotte and Monroe, North Carolina, impermissibly disclosed a patient’s PHI on a webpage in response to a negative online review. The practice did not respond to OCR’s data request, did not respond or object to an administrative subpoena, and waived its rights to a hearing by not contesting the findings in OCR’s Notice of Proposed Determination. OCR imposed a $50,000 civil money penalty.
A dental practice in Fairhope, Alabama, who impermissibly disclosed its patients’ PHI to a campaign manager and a third-party marketing company hired to help with a state senate election campaign, agreed to take corrective action and pay $62,500 to settle potential violations of the HIPAA Privacy Rule.
A psychiatric medical services provider with two office locations in California, agreed to take corrective actions and pay OCR $28,000 to settle potential violations of the HIPAA Privacy Rule, including provisions of the right of access standard.
If you would like to read about other fines, follow this link:
There are many different types of “audits”, so when we refer to audits, we are referring to a “HIPAA audit”. When anyone mentions HIPAA audit, most practices think it won’t happen to them. I hear so often; I have never seen the “HIPAA Police” come around and do an audit. Well, they don’t just walk in off the street, but it only takes one patient complaint, a disgruntled employee, or a data breach to trigger an investigation. I have said this MANY times… and I feel the need to repeat it one more time! HIPAA has changed a few times over the years, one thing that has not changed since 1996 – HIPAA compliance is here to stay, and it is not optional.
When an investigation is opened, depending on the documentation you provide will determine whether a desk audit is conducted. For example, many OCR (Office for Civil Rights) investigations find systemic noncompliance with the HIPAA Security Rule, including failures to conduct an enterprise-wide risk analysis, implement risk management and audit controls, and maintain documentation of HIPAA Security Rule policies and procedures. With the “recognized security practices”, the OCR may review a minimum of 12 months of your documentation. The good news is, if you have documented your compliance efforts, you may not be fined or penalized! The OCR is trying to incentivize practices to step up their data security practices. Keep in mind, this must be documented. Just another reason why our clients are moving to our online compliance platform!
Employee mistakes are the typical cause of a security incident or data breach. Someone clicks on a link, opens an infected website, or falls for a phishing scam. This is a HUGE problem; all you have to do is go to the OCR breach portal and you can see for yourself the number of breaches reported for hacking. Educating your staff is #1, along with good data security practices that are documented.
Lost or stolen devices are also a problem unless they are encrypted. Security incidents must be reviewed, and the outcome documented. If a device is lost or stolen and it is encrypted (and documented as such) it is not a reportable breach!
Another area that the OCR reviews (depending on the complaint or violation) is employee training. HIPAA training requires periodic updates, and it is recommended that all staff including physicians attend annual HIPAA training. Again, this must be documented.
Background checks are so important and often overlooked. I can’t stress this enough… background checks are more than calling the “references” the candidate offers you. Of course, they will give glowing reviews! Insider threats are becoming more of a problem. People pose as a “great” employee, only to steal patient information, or some may just be curious and open patient records that they are not authorized to. Both situations can lead to data breaches or violations. Utilizing a professional company to conduct your background checks will provide you with the appropriate documentation.
Have you noticed something that all these areas have in common? DOCUMENTATION! If is not documented, it doesn’t exist in the eyes of the OCR.
Do you know why the OCR is coming down hard on the lack of data security? Because patient data is valuable, and hackers and scammers are trying to get to YOUR patient data. This is some of the most sought-after information because it contains everything needed to steal a person’s identity. It is easy to get a new credit card number, but you can’t get a new social security number. One more thing, some identity thefts lead to medical identity theft. This can be deadly if someone’s medical information is changed.
These are just friendly reminders to keep your practice safe and secure!
To find out more about how our online HIPAA Keeper™ can help your organization with HIPAA Compliance click here:
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”
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”