The Department of Health and Human Services has been distributing $175 billion to “eligible healthcare providers” on the front lines of the coronavirus response in various phases, but that money comes with many obligations. Failure to comply with all the requirements can result in substantial liability.
Covered entities should take note of some key findings from audits conducted by the OCR in 2016 and 2017. OCR assessed covered entities’ and business associates’ compliance with selected provisions of HIPAA rules.
The enforcement of white-collar crime laws in the healthcare sector is likely to expand under the Biden administration, particularly regarding fraud associated with the billions of dollars in grants Congress allocated to hospitals and other health providers for pandemic relief.
A covered entity’s victory over proposed penalties from the Department of Health and Human Services was good news for those responsible for HIPAA compliance, showing that good faith efforts and a willingness to fight the allegations can pay off.
Patients will no longer have to go through the discovery process during litigation to find out everything ED providers charted. Still, with patients reviewing all the clinical documentation, plenty of misunderstandings can happen.
Pretend surveys may reassure the organization that compliance is good and it is ready for a real survey — or it can unearth deficiencies that should be corrected before they result in real penalties. In most cases, it is a mixture of both.
If an IRB sets a goal of greater efficiency, then giving researchers self-assessment tools and using self-auditing tools on IRB operations is a method that can work. These tools can help study coordinators and investigators turn their study protocol submissions from a hot mess into a submission that is mostly compliant and easier to pre-review.