Many health care organizations struggle to comply with required HIPAA regulations and many have forfeited important Merit-base Incentive Payment System (MIPS) incentive funds. Aligned Risk Management is here to ensure that every health care organization can affordably comply with HIPAA and MIPS. Below are four simple steps you can take today.
Visit our HIPAA site.
Call or email for a free HIPAA checkup.
Take advantage of our low cost, comprehensive HIPAA privacy and security risk assessment.
Have an easy conversation with our certified HIPAA professional and gain confidence about your current HIPAA and MIPS readiness, or find out what steps you can take to benefit your organization and patients.
Take advantage of our low cost, comprehensive HIPAA privacy and security risk assessment.
Federal HIPAA regulations and the advancing care information (ACI) category of MIPS require you to perform an audit-worthy security risk analysis and complete a risk management plan to become HIPAA and MIPS compliant. Aligned Risk Management will guide you through the process and provide you with the policy and procedure templates, tools, and materials necessary to comply with HIPAA, pass an audit, and receive the MIPS incentives you deserve.
Whether you are new to HIPAA or just need a refresher, you will find our HIPAA webinars informative and helpful. Join us as we share our HIPAA knowledge and experience, and answer your HIPAA questions.
A Risk Management Plan is the part of your compliance approach that plans, identifies, and analyzes risks.
Parts of a Risk Management Plan
Risk Response Plans
Risk is defined by the Project Management Institute as an uncertain event or condition that, if it occurs, has a positive or negative effect on one or more project objectives. Risk management is the process of identifying, analyzing, mitigating, and communicating risks.
All systems have vulnerabilities. The US Department of Health and Human Services defines a vulnerability as:
[a] flaw or weakness in system security procedures, design, implementation, or internal controls that could be exercised (accidentally triggered or intentionally exploited) and result in a security breach or a violation of the system’s security policy.
The US Department of Health and Human Services defines a risk as:
The net mission impact considering the probability that a particular [threat] will exercise (accidentally trigger or intentionally exploit) a particular vulnerability and the resulting impact if this should occur.
Risks arise from legal liability or mission loss due to:
Unauthorized (malicious or accidental) disclosure, modification, or destruction of information; Unintentional errors and omissions; IT disruptions due to natural or man-made disasters; Failure to exercise due care and diligence in the implementation and operation of the IT system.
When a risk event occurs, it is no longer uncertain. It becomes an issue.
Risk is a function of the likelihood of a given threat exercising a particular potential vulnerability, and the resulting impact of that adverse event on the organization, mitigated by controls. The relationship among these five concepts forms the basis of our risk assessment approach, which can be thought of as a formula:
The risk level is calculated using three underlying components:
Likelihood: The probability of the event happening. How likely is it that a threat acts on the vulnerability?
Impact: The consequences of the risk event. What happens if the threat acts on the vulnerability?
Effectiveness of Existing Controls: Existing controls and their effectiveness at mitigating risk. What is being actively done to mitigate the effects of a risk?
Likelihood × Impact − Controls ⇒ Risk Level
To illustrate, a plane crashing into your office has a high impact, but a low probability. In fact the probability is so low that the overall risk is probably insignificant. On the opposite end of the scale, a road construction project getting delayed due to rain is an event with a low impact but a high probability of occurrence. Thus, it is a significant risk.
What projects have been completed in the past and what unexpected issues occurred?
What was the response of the organization?
What permanent changes were made? Were they justified?
Did the response cause a corresponding loss of business?
Did the response cause a corresponding loss of future projects?
Another part of the risk planning portion of the Risk Management Plan is the definition of risk levels. Here is an example:
Very Low: The event is highly unlikely to occur under regular circumstances.
Low: The event is unlikely but should be noted by the project team.
Medium: The event has a normal chance of occurring and the project team should be aware of it.
High: The event has a reasonable chance of occurring. It should be regularly discussed and mitigation actions taken.
Very High: The occurrence of the event should be actively managed and mitigation actions taken.
Aligned Risk Management breaks down risk levels into four categories: Negligible, Marginal, Serious, and Critical.
Theoretical risk. Unlikely to be a serious concern.
Vulnerability is very unlikely to be exercised, OR
Existing controls are highly effective at mitigating the risk, OR
Potential impact on security, privacy and availability of ePHI is low
Unlikely to be an immediate concern, especially in light of other, more severe risks.
Some likelihood that vulnerability could be exercised
Existing controls provide some effective mitigation of risk
Potential for significant impact on operations. Effective Risk Management or reasonable plan for such recommended in near future.
Vulnerability is likely to be exercised
Existing controls provide inadequate mitigation of risk
Potential for significant impact on security, privacy or availability of ePHI
Failure to implement controls required by HIPAA. Potential liability and exposure to penalties. Potential for malicious exploitation. Exercise of vulnerability could cause mission-critical damage to business operations. Prompt intervention strongly recommended.
Vulnerability is very likely to be exercised or is currently being exercised
Existing controls provide little effective mitigation of risk
Potential for high or even catastrophic impact on security, privacy or availability of ePHI
A good brainstorming tool is to consider the assumptions made by the project. Most projects have disclaimers in their underlying contracts absolving the performing party of various obvious risks, but what about the next most obvious ones?
What assumptions has the project budget made?
What assumptions has the project schedule made (completion date, milestones, etc.)?
What expertise or prior experience does the company have in this work? How long ago was this experience? What areas require additional training?
Which relationships are being assumed to be strong that are not necessarily (owner, sponsor, client, contractor, consultant)?
How many previous projects with similar components have been completed successfully? What were the project issues?
Stay tuned for Part 2 of Aligned Risk Management’s series, Critical Parts of a Quality Risk Management Plan.
Aligned Risk Management helps healthcare organizations streamline and simplify HIPAA compliance efforts so that you can get back to providing the critical services your patients need. Our expert consulting staff works with you to ensure the privacy, security, and integrity of your systems. This specialized knowledge makes us the leading consulting firm for HIPAA compliance and healthcare risk management.
We’ll play defense so you don’t have to…
Defense of protected health information and the security of your systems is important to the safety of your patients. But it is also critical to the success of your practice. Data privacy concerns make headlines every day, and healthcare companies are especially vulnerable to the effects of unaddressed risk. Patient concern is growing. Regulations are poised to become more demanding. You want to concentrate on better serving your patients, and we make that possible.
…but our process doesn’t stop with just a risk assessment.
It doesn’t stop there. Risk management is a process, so our program includes regular follow-ups to make sure that you are successful. We assist in implementing recommendations and in documenting your efforts to ensure your success in case of an audit. Together, we’ll find high-value solutions that really matter, instead of wasting resources on unnecessary tools or time-consuming procedures that do not fit the way your organization operates.
Compliance with HIPAA can feel overwhelming. The most frequent question we hear is “Where do I start?” Start right here with Aligned Risk Management, and put yourself ahead of the curve.
HIPAA fines are up. Audits by the Department of Health and Human Services are up. 2019 is shaping up to be a rather tumultuous and dangerous year for healthcare providers as they ramp up to address their HIPAA privacy obligations.
And here are four steps to start out ahead this year….
1. Do SOMETHING.
There are so many different ways to start tackling another aspect of HIPAA. Are you wanting to make some headway in implementing technical safeguards? Great! Two-factor authentication. What about administrative safeguards? Awesome. Update your workforce sanctions policy and make sure it’s realistic. What about physical safeguards? Get those contingency operations plans updated. Whatever you decide to do, you’ll have to start somewhere.
“When eating an elephant take one bite at a time.”
Creighton Williams Abrams Jr.
I never said that eating the HIPAA elephant was going to be easy. But since you have to, you might as well start with one bite at a time. Approach HIPAA like you would an elephant and you’ll be surprised at just how much you can accomplish in a short period of time.
2. Business Associate Agreements
I’ve seen a lot of embarrassingly insufficient business associate agreements (BAA). As a recap, a “business associate” is likely a vendor to a healthcare provider, other than a member of the workforce of a covered entity, who provides certain services to a covered entity. Remember, this service directly involves access by the business associate to protected health information (PHI).
Among other confusing relationships that can exist between entities, a covered entity can be a business associate to another covered entity.
As part of your approach to HIPAA in 2019, perhaps it’s time to evaluate the relationship between yourself and your vendors, or between yourself and your clients. Are you a covered entity? Are you a business associate? Do you have business associates?
Once you’ve done some review of those relationships and you’ve identified all your vendors and business associates, it’s time to review those business associate agreements.
Cookie cutter policies aren’t going to cut it. In this industry, so highly regulated by HHS, it’s highly unlikely that you’ll get away with taking any shortcuts. Let’s tackle your policies and procedures and how they relate to the realistic operations of your organization.
Are they accurate? I mean, do your policies accurately reflect how your workforce carries out their day-to-day operations? If you’re documenting in your policies that your workforce implements rigorous access revocation procedures upon employee termination, but this isn’t being practiced regularly by your IT staff, that’s not good. You’re saying that you’re doing this, but if that can’t be proven and is likely to be disproved by the dozens of former employee accounts that haven’t been deactivated, HHS will certainly have a field day. At your expense.
Don’t let that happen. Get on top of your policies and procedures. Make sure they’re honest and truthful. Maybe it’s time to actually change some operations and procedures to better protect patient privacy. Maybe you’ll learn something about your own organization. It’s another bite you can take out of the HIPAA elephant. It’s getting smaller!
4. Risk Assessment
Calling in the experts can be totally nerve-racking. You’re inviting others into the sensitive operations of your organization, exposing your internal practices to a stranger. We’re not the bad guys. We’re here to help you.
Updating your risk assessment can give you invaluable insight into modern best-practices that you weren’t aware of. It can make you aware of problematic business operations that really ought to be corrected and streamlined.
And best of all, you’ll get a great plan for continuous improvement: a plan consisting of the best actionable steps you can take to make the most impact in mitigating risk at your organization.
The final version of the NIST Risk Management Framework 2.0 is now available, providing government agencies and commercial enterprises alike with new guidance that aligns risk, privacy and cyber-security controls.
The National Institute of Standards and Technology is out with the final version of its Risk Management Framework (RMF) 2.0 update, providing organizations with new detailed insight into how to define and manage risk.
RMF 2.0 was officially released on Dec. 20 and follows seven months of consultation and comments. RMF 2.0 is formally titled NIST Special Publication (SP) 800-37 Revision 2 and outlines how federal agencies and those that wish to align with the standard can address security and privacy risk management. Among the key additions in the RMF 2.0 updates is an alignment and integration with the NIST Cybersecurity Framework, which outlines controls and processes that should be used by U.S. government agencies.
“RMF 2.0 gives federal agencies a very powerful tool to manage both security and privacy risks from a single, unified framework,” NIST’s Ron Ross, one of the publication’s authors, wrote in a media advisory. “It ensures the term compliance means real cybersecurity and privacy risk management—not just satisfying a static set of controls in a checklist.”
RMF 2.0 itself is a lengthy report of 183 pages that is freely available. The report noted that organizations implementing the RMF will be able to maximize the use of automated tools to manage security categorization as well as control selection, assessment and monitoring.
“The RMF provides a dynamic and flexible approach to effectively manage security and privacy risks in diverse environments with complex and sophisticated threats, evolving missions and business functions, and changing system and organizational vulnerabilities,” the RMF states. “The framework is policy and technology neutral, which facilitates ongoing upgrades to IT resources and to IT modernization efforts—to support and help ensure essential missions and services are provided during such transition periods.”
The RMF 2.0 includes a long list of tasks that includes an outline of risk management roles within an organization as well as strategy. Identifying common controls as well as having a continuous monitoring strategy is another key component that is part of RMF. Risk itself is at the core of RMF 2.0, with the requirement that organizations execute a risk assessment that includes all assets that need to be protected.
“As a key part of the risk assessment, assets are prioritized based on the adverse impact or consequence of asset loss,” RMF 2.0 states. “The meaning of loss is defined for each asset type to enable a determination of the loss consequence (i.e., the adverse impact of the loss).”
NIST’s guidelines for cyber-security have become foundational elements in the product portfolios of multiple vendors that align their offerings to help enable organizations with governance, risk and compliance (GRC) needs. Multiple industry experts contacted by eWEEK were enthusiastic about the improvements made in the RMF and how it will help improve cyber-security overall.
“We view the NIST Risk Management Framework (RMF) as further refinement of NIST’s message around the practice of risk management and a bridge in the continuation of their guidance encompassing security of the organization, individual privacy, and organization-wide risk management,” Steve Schlarman, risk management strategist at RSA, told eWEEK. “We have long been committed to the belief that in order to effectively and efficiently manage information security, you have to take a risk-based approach.”
McAfee’s chief policy officer and head of government affairs, Tom Gann, is also supportive of RMF 2.0. He noted that the NIST Cybersecurity Framework presents a rational, step-by-step approach to identifying and managing an organization’s cyber-security risk.
Abdul Rahman, chief data scientist at Fidelis Cybersecurity, commented that from his perspective looking at the RMF 2.0 update, the focus is on enhancing the protection of individuals’ sensitive data.
“Organizations need to go beyond threat prevention—we’ve already seen that preventive tools alone don’t suffice against motivated and sophisticated attackers,” Rahman told eWEEK.
Istvan Molnar, product marketing manager and compliance specialist at One Identity, also sees as noteworthy the emphasis on privacy in RMF 2.0. Molnar said the RMF 2.0 document specifically calls out the need for organizations to “consider how to best promote and institutionalize collaboration between the two Privacy and Information Security programs to ensure that the objectives of both disciplines are met at every step of the process.”
“It’s also noteworthy that the report not only refers to access but also ‘system activity or behavior’ going a step further than simply focusing on controlling access to data,” Molnar told eWEEK. “Additionally, the framework promotes the notion of designing risk management into the security and privacy capabilities of information systems throughout the system development life cycle.”
For Meerah Rajavel, CIO at Forcepoint, there are three key takeaways from RMF 2.0. The first is that digital and cyber-security are becoming center seat in the boardroom.
“The RMF Revision 2.0 focusing on linkage and communication to the C-suite governance, and providing guidance on the synergy between Cybersecurity & Risk Management framework, can help elevate the CISO and CIO to be more powerful at the boardroom table,” Rajavel told eWEEK.
She added that the second aspect of interest is the focus on the IT/OT and supply chain, which are crucial to protect critical infrastructure that affects civilians and the economy.
“The third element, which is inspiring in lieu of many recent events, is linking privacy to risk, which helps other compliance and regulations like GDPR, CA Privacy Act, etc.,” she said.
Are medical device or pharmaceutical companies designated as a qualifying entity subject to HIPAA and HITECH?
Classifying the entity
Are medical device or pharmaceutical companies designated as a qualifying entity subject to HIPAA and the HITECH Act? Yes. In general, a provider that “transmits any health information in electronic form in connection with a transaction covered by this subchapter” is considered a covered entity. Moreover, according to the 45 CFR §160.103(2)(ii)(3), “a covered entity may be a business associate of another covered entity.” In fact, CMS recognized that as a government agency, it is subject to HIPAA, the HITECH Act and related rules in an October 2012 report issued by the Office of the Inspector General, “CMS Response to Breaches and Medical Identity Theft.”
In turn, a business associate, as defined by the HIPAA Rules, is “a person who performs functions or activitieson behalf of, or certain services for, a covered entity that involve the use or disclosure of protected health information” (emphasis added). A subcontractor is a person who contracts with a business associate and stores, handles or transmits PHI. Regardless, under Section 164.308(b) of the Security Rule and 164.502(e) of the Privacy Rule, a covered entity or business associate is required to enter into an arrangement known as a business associate agreement to provide parameters and some legal protection when a contracted entity is handling PHI.
Effective Feb. 18, 2010, Section 13408 of the HITECH Act provides that health information organizations, e-prescribing gateways, vendors of personal health records and other persons that facilitate data transmission and require access to PHI, regardless of their status as a covered entity, business associate or subcontractor, are subject to business associate agreements in accordance with the HIPAA Rules.
Therefore, medical device and pharmaceutical companies can be classified as a qualifying entity subject to HIPAA and the HITECH Act. As such, they are subject to handling, storing and transmitting in accordance with the requisite laws and regulations. The consequences from civil and criminal monetary penalties alone are significant. Since the HITECH Act expressly expanded HIPAA’s requirements to business associates and subcontractors, the same standards for access to medical records, business associate agreements and other provisions equally apply.
Patient access rights
The tension between patients wanting to have access to their health data from a medical device, which is implanted in them, and a medical device company is highlighted. According to a representative of a medical device maker quoted in the article, “Federal rules prohibit giving Ms. Hubbard’s data to anyone but her doctor and hospital. Our customers are physicians and hospitals.” In general, 45 C.F.R. §164.524, Access of Individuals to Protected Health Information, sets forth the parameters of the HIPAA Privacy Rule. Included in these standards are the circumstances for providing protected health information to a patient and exceptions. Nothing in the scenario of the PHI being transmitted from a patient’s implant to a medical device company, who would be classified as a business associate in this instance invokes an exception to deny the patient’s request.
Section 13410(d) of the Health Information Technology for Economic and Clinical Health Act authorizes penalties to be assessed for violations of the Privacy Rule. In February 2011, HHS issued a Final Notice of Determination and held Cignet Health, a business associate, liable for $4.3 million in civil monetary penalties when they denied 41 patients access to their medical records. As OCR Director Georgina Verdugo indicated, “covered entities and business associates must uphold their responsibility to provide patients with access to their medical records, and adhere closely to all of HIPAA’s requirements.” And, “The U.S. Department of Health and Human Services will continue to investigate and take action against those organizations that knowingly disregard their obligations under these rules.” This area should be considered in drafting business associate agreements. Therefore, business associates such as Medtronic are required to release the PHI to the patient requesting the information, unless one of the exceptions is met, and the patient is informed.
We have our [redacted] website but just found that our substance abuse team has created another website that just specifically address addiction and the services provided. The only association it has with our office is a small little logo at the bottom of the page. And the telephone number listed goes directly to a staff members cell phone. Do you find this a issue?
Strictly regarding subsidiary websites, there is no violation or problem that arises from this issue alone. Many hospitals and practices enable the use of separate websites when services are differentiated substantially from the parent organization.
However, the problem with the [redacted, subsidiary] team website is that this website was created without the prior express authorization of the parent organization. The website was created and is managed outside of the normal reach of the parent organization and the project was undertaken in violation of the organization’s policies and procedures (this is assumed, based on unseen policies and procedures).
The inclusion of a staff member’s cell phone number on the site as the primary method for contacting the substance abuse team creates a problem with chain of custody. A patient suffering from substance abuse might leave sensitive information in a voicemail left on the staff member’s cell phone. Without being able to guarantee any assurances as to the privacy and security of this potentially sensitive information, such an incident could be considered an unauthorized disclosure.
Depending on the organization’s policies and procedures regarding a BYOD (bring your own device) policy and mobile device management, this creates a continual vulnerability for sensitive information to be disclosed, unintentionally or otherwise.
Additionally, the substance abuse website might not sufficiently publicize the organization’s notice of privacy practices (this is assumed, based on unseen website).
Suggested corrective action
The website should immediately be brought under the direct control of the parent organization, be made so that the site is not publicly accessible until corrective action is completed, and evaluated by the designated individuals responsible for website maintenance. Any deficiency should be brought into compliance in accordance with the organization’s policies and procedures. The staff responsible for acting outside of the organization’s policies and procedures should be made aware of the problems their actions have caused, along with appropriate disciplinary sanctions.
What are possible threats to protected health information (PHI), electronic (ePHI) or otherwise?
The US Department of Health and Human Services defines a threat as “the potential for a person or thing to exercise (accidentally trigger or intentionally exploit) a specific vulnerability.” Threats are broken down into three categories:
Environmental: referring to immediate physical environments, such as offices or data centers
Natural: referring to weather, natural disasters, mass human events, and Acts of God
Human: referring to individuals who could cause harm, either inadvertently or negligently, or intentionally and maliciously
Aligned Risk Management has identified the following reasonably-anticipated threats to the security, privacy and availability of ePHI.
Internet outage: Failure of application server to connect to internet, failure of DNS servers to resolve server domain name, upstream connection failure, and other internet outages.
Power outage: Failure of power systems at the data center, failure of power supply to the data center, and other power outages.
Hardware failure: Failure of any hardware component of the server or data center where the application is hosted. Refers to failures caused by wear, age, design flaws, and other inherent hardware weaknesses.
Software failure: Failure of any application, operating system or other software component to operate as intended. Includes malware infections, data corruption, functional failures.
Site pollution: Fire, spills, accidents, etc.
Floods, earthquakes, tornadoes, landslides, etc.: Any unpredictable large-scale threat over which humans have no control. Also includes mass human events, such as war, terror attacks, strikes, epidemics, alien invasions, zombie apocalypse, etc.
Internal threats: Authorized users, staff, Business Associates, trusted advisors, etc. The least dramatic but most common threats to the security, privacy and availability of ePHI.
Inadvertent disclosure of ePHI: Unintentional action by authorized user or failure of Application that inadvertently discloses any ePHI to any unauthorized user
Inadvertent data entry, modification or deletion: User error. Accidental and unintentional action or omission by an authorized user that causes damage to the security or availability of ePHI
Malicious disclosure of ePHI by authorized user: Deliberate disclosure by authorized user who intends to obtain some personal gain or to cause harm
Malicious destruction of ePHI by authorized user: Deliberate sabotage by authorized user who intends to cause harm
External threats: Ex-employees, hackers, thieves, etc.
Unauthorized observation of ePHI: Unauthorized person is able to observe improperly-controlled ePHI
Unauthorized person gains access using genuine credentials: Attacker successfully logs into a controlled system using a genuine username and password or other credentials of an authorized user
Technological attack against a controlled system: Attacker exercises a technological vulnerability of an ePHI system still controlled by the covered entity
Technological attack outside any control or response: Attacker gains indefinite physical control of an ePHI system and is able to exercise vulnerabilities without detection or intervention by covered entity
Social engineering: Attacker uses psychological manipulation to induce authorized users to act against security policies or divulge confidential information
Malicious destruction of ePHI by unauthorized user: Deliberate sabotage by attacker who intends to cause harm
Civil liability for failure to implement HIPAA-mandated specification: Failure to implement or adequately document certain required polices and procedures
Civil liability for failure to follow documented policies: Failure to implement or adequately document certain required polices and procedures