Quietly, at the end of April, HIPAA was significantly weakened. HHS published what sounds like an innocuous notification in the Federal Register: Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties. This notification is actually an enormous change to the HIPAA penalty structure, a drastic reduction in HIPAA fines.
The existing penalty structure under HIPAA is based on the HITECH Act of 2009, which increased HIPAA’s fines in an attempt to give teeth to HIPAA enforcement. Since HIPAA began being enforced in 2003 until the HITECH Act, fines had barely been issued despite an enormous amount of HIPAA violations. HITECH was Congress’s rebuff to this weak enforcement approach. After HITECH’s more potent penalty structure, HHS finally began issuing fines. The chart below is how HHS has been interpreting the HITECH penalty framework since the HITECH Act:
There were some ambiguities under the HITECH Act as to these penalty tiers, but HHS had long interpreted these tiers according to the above chart. But now, HHS has suddenly changed its mind and adopted a very different interpretation. Under this new interpretation, the penalty tier limits are now as follows:
Notice the new annual limits. There are severe reductions in the annual limits for nearly every category except for uncorrected willful neglect. This change yanks many of the teeth out of HIPAA enforcement.
A study released last month in Jama Open Network entitled Assessment of US Hospital Compliance With Regulations for Patients’ Requests for Medical Records demonstrates that compliance with HIPAA’s right to access medical records remains woeful. In the second half of 2017, researchers contacted 83 US hospitals and conducted a simulated patient experience to ask for medical records. Among the hospitals, the researchers found that “there was discordance between information provided on authorization forms and that obtained from the simulated patient telephone calls in terms of requestable information, formats of release, and costs.” On forms, “only 53% provided patients the option to acquire the entire medical record.” The study concluded that “Requesting medical records remains a complicated and burdensome process for patients despite policy efforts and regulation to make medical records more readily available to patients. Our results revealed inconsistencies in information provided by medical records authorization forms and by medical records departments in select US hospitals, as well as potentially unaffordable costs and processing times that were not compliant with federal regulations.”
I addressed this topic in a blog post about 2 years ago. At that time, I said:
HIPAA doesn’t handle patient access to medical records very well. There are many misunderstandings about patient access under HIPAA that make it quite difficult for patients to obtain their medical information quickly and conveniently. Getting records is currently like a scavenger hunt. Patients have to call and call again, wait seemingly forever to get records, and receive them via ancient means like mail and fax. I often scratch my head at why fax is still used today — it’s one step more advanced than carrier pigeon. Many covered entities do not send records by email, and getting electronic copies can be quite difficult. Many healthcare providers still maintain paper records in handwriting, and healthcare lags far behind most other industries in the extent to which it has moved to digital records.
Sadly, as this study confirms, little has changed.
Have you ever asked your healthcare provider to send you medical records by email? Most likely, you’ve received the reply: “We can’t do that. We can only fax them to you or provide you with a paper copy.” This answer is wrong.
HIPAA’s right for individuals to access their health information, 45 CFR § 164.524, provides:
The covered entity must provide the individual with access to the protected health information in the form and format requested by the individual, if it is readily producible in such form and format; or, if not, in a readable hard copy form or such other form and format as agreed to by the covered entity and the individual.
Recently, I created two new HIPAA training resources.
I created a 1-page visual summary of HIPAA, which I call the HIPAA Whiteboard. The idea was to summarize HIPAA in a concise and visually-engaging way. You can download a PDF handout version here. We’ve been licensing it to many organizations for training and awareness purposes.
HIPAA Interactive Whiteboard
I subsequently created a new training module — an interactive version of the HIPAA Whiteboard — the HIPAA Interactive Whiteboard. When people click on each topic, the program provides brief narrated background information, presented in a very understandable and memorable way. Trainees can learn at their own pace. This program is designed to be very short — it is about 5 minutes long.
It can readily be used on internal websites to raise awareness and teach basic information about HIPAA. It can also be used in learning management systems.
At the end of 2017, the OCR logged just under $20 million in fines for HIPAA violations from 10 enforcement actions with monetary penalties. In 2016, the total in penalties was roughly the same amount but from 15 organizations.
Here is an overview of the resolution agreements and enforcement actions with civil monetary penalties from 2017:
Lessons from 2017
Devices, devices, devices . . .
Quite a number of cases involved failure to implement safeguards for PHI on mobile devices. The best fix is to superglue devices to staff. Short of doing that, organizations should recognize that mobile devices frequently get lost or stolen, so there should be heightened security controls when PHI is accessible on these devices.
Several cases involved failing to provide timely notice or to act promptly after problems were discovered. In politics, it’s often not the scandal, but the coverup that fells politicians. In the world of HIPAA, it’s often not the incident, but the response that leads to organizations being penalized.