The complaint, received in August 2018, involved a mother who waited over 9 months to receive prenatal records from Bayfront Health in St. Petersburg. She requested the records of her unborn child in October 2017 and after receiving incomplete records in March 2018, she did not receive the complete records until August 2018 (via her lawyers). It was not until after the OCR’s investigation in February 2019 that she received the complete records directly. HIPAA requires medical records to be provided within 30 days of the request.
The OCR concluded that Bayfront violated 45 C.F.R. § 164.524 by failing to provide access to PHI. Bayfront has paid $85,000 and agreed to a corrective action plan. The corrective actions include written policies and procedures around access rights, increased training and incident reporting among others.
I applaud the OCR bringing this case, but it is quite shocking that this is the first enforcement action with a fine for a violation of the right to access in HIPAA’s history. More than 15 years went by before this single action. A lot more enforcement must start happening.
One of the biggest sore spots in HIPAA compliance has been providing individuals with their right to access their medical records. In addition to the countless anecdotal accounts about the painful process of getting medical records, a recent study demonstrated just how far there is to go for providers to be in compliance. More than half of medical providers included in the recent medRxiv study did not meet the basic requirements in HIPAA for providing medical records. A further 20% of the providers would not provide records until requests were escalated to supervisors. Which means that more than 70% of the subjects studied would not have been in compliance had the supervisors not been involved.
HIPAA provides that “an individual has a right of access to inspect and obtain a copy of protected health information about the individual in a designated record set, for as long as the protected health information is maintained in the designated record set.” 45 CFR §164.524
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.
Massachusetts — $75,000 settlement with McLean Hospital for a data breach involving 1,500 victims based on an employee who routinely took home unencrypted backup tapes with PHI. From the state press release:
The AG’s complaint alleges that McLean, a psychiatric hospital in Belmont, allowed an employee to regularly take home eight unencrypted back-up tapes containing clinical and demographic information from the Harvard Brain Tissue Resource Center that the hospital possessed. The tapes contained personal information such as names, social security numbers, diagnoses and family histories. When the employee was terminated from her position at McLean in May 2015, she only returned four of the tapes, and the hospital was unable to recover the others.
New Jersey — $100,000 settlement with EmblemHealth for a 2016 breach involving 81,000 victims. Details from the state’s press release:
The incident at issue took place on October 3, 2016 when EmblemHealth’s vendor sent a paper copy of EmblemHealth’s Medicare Part D Prescription Drug Plan’s Evidence of Coverage to 81,122 of its customers, including 6,443 who live in New Jersey.
The label affixed to the mailing improperly included each customer’s HICN, which incorporates the nine digits of the customer’s Social Security number, as well as an alphabetic or alphanumeric beneficiary identification code. (The number shown was identified as the “Package ID#” on the mailing label and did not include any separation between the digits.)
During its investigation, the Division found that following the departure of the EmblemHealth employee who typically prepared the Evidence of Coverage mailings, the task was assigned to a team manager of EmblemHealth’s Medicare Products Group, who received minimal training specific to the task and worked unsupervised. Before forwarding the data file to the print vendor, this team manager failed to remove the patient HICNs from the electronic data file.
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.”
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.