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Indigenous People Grill NIH on All of Us Protections

Attempting to reassure an indigenous community that has been abused in past research, the NIH All of Us precision medicine initiative is holding a series of meetings and webinars with the National Congress of American Indians. A key part of the dialogue is letting American Indian/Alaska Native Tribal Nations ask questions and express concerns about the project.

Identifiable Data Are Not What They Used to Be

IRBs and researchers should change their old habits when it comes to assessing studies for privacy and confidentiality. Researchers recently showed that de-identified data could be used to find a specific person. Using a mathematical model in databases of more than 200 populations, researchers found they could correctly re-identify 99.98% of Americans, using 15 demographic attributes.

Tips for IRBs Reviewing Pragmatic Trials

Flexibility is needed when reviewing pragmatic clinical trials, which typically enroll a broader population of patients and might need more adaptable informed consent than traditional clinical trials. Researchers have raised questions about how pragmatic trials should be regulated and what IRBs should do to protect participants, but not discourage this type of research.

Pragmatic Trials on the Rise as Data Collection Pushes Trend

Several recent changes are driving the pragmatic trial trend nationally, including acceptance from regulators and the growth of big data. Pragmatic clinical trials measure effectiveness of a study drug, device, or intervention on a wider range of people. Unlike clinical trials that exclude people based on health conditions and other criteria, pragmatic trials study a treatment’s effect on a group of people who are more representative of patients in clinical practice and the real world.

Calls for IRB Transparency in a Closed-Door System

It is a common critical observation in human research that IRBs operate in a sort of “black box,” making decisions that could greatly affect a general public that remains largely oblivious of their role and function. This default ought to change toward transparency, both for the good of the research community and to be in line with the increasing calls for publishing research results, reporting all clinical trial data, and sharing consent forms, experts say.

Appellate Court Rejects Loss-of-Chance Argument for Patient Who Suffered Stroke

This case reveals a potent defense for physicians and care providers: A patient must prove causation when raising a malpractice allegation. A plaintiff must prove that the physician or care provider’s conduct is a substantial factor in causing the harm, which means that it must be more than a remote or trivial factor. However, it does not have to be the only cause of the harm. If the harm would have occurred without the physician or care provider’s conduct, then the conduct was not a substantial factor in causing harm.

Patient Loses Eye to Improper Sterilization of Surgical Equipment; Awarded $3.5 Million

The lessons from this case include the importance of proper sterilization, as well as the legal procedures and appeal options. The appellate court noted that the hospital did not dispute the possibility that a breach in the sterilization process had occurred; instead, the hospital focused its challenge on the fact that the patient had not presented convincing evidence demonstrating that the breach in sterilization practices had caused the infection.

Future for Risk Managers Will Require Flexibility, Learning

Risk managers seeking to improve their careers must evolve continually with the changing healthcare landscape. There are new technologies to consider, along with value-based reimbursement models, that are dependent on quality patient outcomes. Healthcare delivery models continue to bring new and sometimes unfamiliar services and exposures to an organization.

Address Metadata With Protocol for Subpoenas

A strict protocol for responding to subpoenas can reduce the risks that come with inadvertently releasing too much information, or the wrong information. Experts have found that the best practice for responding to subpoenas or authorizations for production of medical records in legal cases is to set up a special department or designate an employee as the legal health information management representative. All requests for records in a legal case would be funneled through a person or persons trained in the legal issues and with ready access to the legal department or outside legal counsel when questions arise.

Protect Metadata When Disclosing Information From Electronic Health Records

Information from electronic health records can contain metadata that are not immediately recognizable to the user, but could contain specific protected health information about patients. Inadvertently providing this metadata could provide useful information to the opposition in a malpractice case, and could create other problems for the patient.