By Gary Palgon, VP Healthcare Solutions, Liaison Healthcare Informatics
Although the mandate to purchase health insurance is one of the most well-known aspects of President Barack Obama’s Patient Protection and Affordable Care Act, the bill also encourages digitization of health and medical records. This puts huge quantities of data in electronic form, making it much easier to organize and transmit.
In addition to patient care, what can this data be used for?
One purpose is pharmaceutical research. The data generated by clinical providers dwarfs the data produced—and owned—by pharmaceutical companies’ clinical trials. This is especially apparent after a product is launched. This data can be used in the different predictive models used for future drug development.
The PPACA’s language dealing with digitization of health-care records includes facilitating medical research as a purpose of data collection. However, the Health Insurance Portability and Accountability Act permits the use of identifiable patient information without patient consent for general health-improvement research only, while the Common Rule covers research funded by certain federal agencies. Although consent is not necessary if the patient is dead and the consent requirements can be waived in some circumstances (one example being if the risk of privacy loss is minimal), research authorizations must be specific to a project and compound authorizations are not permitted. The HIPAA and Common Rule regulations governing anonymous data, however, are looser. The data must be stripped of sixteen different types of identifiers like date of birth, but then it can be used without patient consent. Once “de-identified,” it can be used for any purpose.
Issues of concern involve different interpretations of the federal and state laws governing secondary usage of data, which could be problematic for entities unused to secondary use of medical data.
Like anything else involving change, the healthcare industry, patients included, will take time to balance out the benefits of sharing patient data for secondary use as many have already found when diagnosed with terminal illnesses in the past.
On a side note, I would like to congratulate our online Scavenger Hunt winner – Jennifer Moore from Green Clinic Surgical Hospital. We will be in touch with Jennifer, and others who answered all the questions correctly, shortly.
Until next time,