A Growing Problem for Healthcare Organizations The opioid crisis and drug addiction are not just among criminals. The issue is growing among all segments of the population including healthcare workers. This is a multi-faceted problem. There are patient safety issues, fraud and abuse issues, and regulatory compliance issues just to name a few. Healthcare facilities are expected to have controls in place to help ensure drug diversion is not occurring and to identify and resolve instances when it does
Monitoring and auditing of access to protected health information by many organizations is prompted by patient complaints or some other event triggering the need to conduct an investigation. This is reactive or for-cause access monitoring and auditing which is necessary but organizations should also be doing proactive, not-for-cause auditing and monitoring. Under HIPAA Security Rule, covered entities and business associates have an obligation to have policies and procedures in place to prevent, detect, contain and correct security violations. 45 CFR 164.308(a)(1)(i).
Security of an organization’s printers and multi-function devices, as well as the data on those devices, is handled by the IT department, right? While this might be true, compliance and privacy officials should care about what is happening with these devices. It is not uncommon for these devices to have significant data storage capacities, as much as 320 GB. Imagine how many records such a device could hold, as well as the fact healthcare organization will have hundreds if not thousands such devices. Think about what gets printed in a busy clinical area or by the staff in finance or patient quality. These business units often work with large files that include the information of hundreds if not thousands of individuals. Has anyone at the organization ever evaluated the volume of records that get printed by the staff in one of these areas?
The increase of ransomware attacks on healthcare entities and their business associates continues to be a significant concern. While covered entities (CE) have their own issues to deal with when the attack is directly against the organization, there are additional considerations if the attack is on a business associate (BA). This issue was recently raised when there was a reported attack against a BA used by several healthcare entities. The attack was made public, which means the CEs that used the business associate were on notice of the attack.
Petya, or NotPetya as some call it, has shown itself to either be very poorly thought out ransomware, or more likely a full on destructive malware attack thinly veiled as ransomware. In essence, a “traditional” ransomware threats will encrypt specific important file types and show the user a ransom note telling them to pay or lose their data. In the last week of June, we saw something stranger, on the surface it appeared to be a modified version of a known and fairly common ransomware variant called Petya, hence the NotPetya name. However, unlike standard ransomware, where the entire purpose of it is to make money, the ransom payment and recovery mechanisms built into this new Petya variant were very weak. It relied on a single email address (that was promptly shut down) and a single Bitcoin wallet meaning there was virtually no way for the criminals to know who had paid, or which key might be the right one to unlock the data.
Compliance officers everywhere want to believe the compliance program they oversee is effective. Some believe it is effective, some hope it will be found effective and some know the program is not effective because of significant gaps in one or more of the seven elements of an effective compliance program. If you are a believer, ask yourself, “What methods have I established to demonstrate effectiveness?” If you are filled with hope – well hope is not a strategy. If you know your program has gaps, what are you doing to address those gaps? An additional resource now exists to help evaluate effectiveness. The OIG/HCCA Measuring Compliance Program Effectiveness: A Resource Guide released March 27, 2017, provides recommendations on what to measure and how to measure it under each of the seven elements.
Most healthcare organizations today have a compliance program, but how many can say the program is effective and more importantly feel confident they could demonstrate effectiveness? It is not uncommon to hear, “I cannot define effectiveness but I know it when I see it.” Why is this important? All compliance professionals know having a paper compliance program (compliance plan that sits on the shelf along with well drafted but not implemented policies and procedures) is not effective. But as one assesses what an organization is doing as it relates to the seven elements of an effective compliance program based on the Federal Sentencing Guidelines and all the various OIG compliance program guidance documents, the process gets more convoluted. How much is enough, and do you just want to do “the bare minimum”?
Covered entities deal with many complex privacy and information security issues, but institutions that conduct research have an additional level of complexity. Key to understanding the implications of privacy obligations in research is understanding the multiple regulations that could apply to human subject research.
My colleague David Holtzman recently wrote a blog post on the OCR resolution agreement with the University of Massachusetts at Amherst (UMass). UMass designated itself as a hybrid entity but did not appropriately identify and designate all applicable functions that engaged in health care activities as inside the health care components (HCC) of its hybrid entity structure under HIPAA. Why might this not be as easy as it sounds?
For many things in health care, if you don’t spend the energy and resources to reduce risks now you will likely pay for it later. However, if you wait until later it will cost more to take care of the problem than it would have to prevent it. We all know if we eat healthy, exercise and get our routine medical and dental examinations the risk of serious health conditions is reduced. Catching a disease early could mean the difference