Another day, another massive leak.
Researcher Jeremiah Fowler reports that he found unsecured data with 1,674,218 records belonging to DM Clinical Research. DM Clinical Research is a Texas-based network of more than 24 multi-therapeutic clinical trial sites involved in research on vaccines, internal medicine, pediatrics, gastroenterology, psychiatry, neurology, women’s health, and more. DM Clinical Research’s site claims that they have tens of thousands of patients enrolled. Whether that is a lifetime total or current is not clear.
Fowler’s findings were reported by Website Planet:
I saw a trove of potentially sensitive personal and medical information, such as names, dates of birth, phone numbers, email addresses, vaccination statuses (including specific vaccines received), current medications, and other health conditions that the survey recipients may have.
Some surveys also contained notes that included adverse reactions to COVID-19 vaccines, other health problems, doctor’s name, whether the individual was on birth control or pregnant, and the name of the person conducting the survey.
On inquiry, Fowler clarified that some records were questionnaires, some were screening tools, and some appeared to be surveys. DataBreaches notes that although Fowler refers to the data being a “database,” it was actually an Azure blob.
But is DM Clinical Research covered by HIPAA or are they a business associate, or neither?
DataBreaches.net has sent three requests to DM Clinical Research asking them to state whether they are covered by HIPAA or not. They did not reply at all.
As the NIH website explains with respect to researchers and HIPAA:
Covered entities are health plans, health care clearinghouses, and health care providers that transmit health information electronically in connection with certain defined HIPAA transactions, such as claims or eligibility inquiries. Researchers are not themselves covered entities, unless they are also health care providers and engage in any of the covered electronic transactions. If, however, researchers are employees or other workforce members of a covered entity (e.g., a hospital or health insurer), they may have to comply with that entity’s HIPAA privacy policies and procedures. Researchers who are not themselves covered entities, or who are not workforce members of covered entities, may be indirectly affected by the Privacy Rule if covered entities supply their data. In addition, it should be noted that the HHS and FDA’s Protection of Human Subjects Regulations (45 CFR part 46 and 21 CFR parts 50 and 56, respectively) may also apply to clinical research.
DM Clinical Research’s website states, in part:
Every clinical trial we conduct is overseen by one of our own physicians — otherwise known as a Principal Investigator (PI). They believe in the importance of high-quality trials done with care in order to advance life science technologies. They work within their specialty therapeutic areas and ensure each participant is treated with compassion, safety, and professionalism.
DM Clinical Research’s failure to answer a simple question suggests that we should wonder whether they intend to notify any state attorneys general, HHS, or research participants of this leak. Hopefully, they have adequate access logs that can prove whether the data was accessed by unauthorized individuals and their IP addresses.