Alaap B. Shah, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Health Data Management, in "Data Governance in the Age of AI: Beyond the Basics," by Gienna Shaw.
Following is an excerpt:
The guiding question, Shah says: “Is there a specific segment of the population that has an immediate need for innovation in the drug space that we could help support?”
A research and publications committee created a process to vet requests for legitimacy, feasibility and even the character of the organizations before agreeing to share data. The team would also look at the technology an organization would use for the analysis and ensure they had appropriate security safeguards in place. Organizations that didn’t might be credentialed to view limited data in the ACSO’s own system.
In addition to vetting, contracts are crucial, Shah says.
“You need to have contract vehicles that contemplate and hammer out some thorny issues [such as] the data ownership pieces, so everyone knows who owns the data, who’s just licensing it and borrowing it for a short period of time so that you don’t have disputes about that later. You have to hammer out issues [about] de-identified data. You have to be very careful to put in clear language about not linking it, not reidentifying it, not sharing it with other third parties without … assurances in place,” Shah says.
“One of the big problems with the industry today is people don’t appreciate this issue because they don’t want to go through the time and expense of vetting,” he adds. And organizations can contract out that function, but then they run the risk of losing sight of patients’ data privacy.
“We can fight about who’s going to carry the bag at the end of the day. But at the end of the day is when the patient’s privacy interest is lost,” he says.