The Advanced Medical Technology Association (Advamed) said its university technology transfer best practices guidelines was drafted with the help of the law firm of Wilson Sonsini Goodrich & Rosati PC, of Palo Alto, Calif., and is intended to facilitate greater interactions with academic researchers and device makers. The document, authored by Advamed Accel, the association's small business arm, recommends that small med-tech firms approach universities with an expectation that negotiations over licensing agreements may take a considerable amount of time. It added that an offer to draft term sheets may not always be welcomed by the university. Device makers interested in doing business with university technology research departments should consider several considerations, including how much development work would be entailed after the company takes over the development, and whether the payer coverage pathway is likely to remain lucrative, given the rapidly evolving coverage and reimbursement landscape. Intellectual property and premarket regulatory considerations also are highlighted in the guidelines, but the document notes that a device maker's chances of success are enhanced by the exercise of due diligence in the area of a university's mission and conflict of interest policies.
The Office of Inspector General (OIG) at the Department of Health and Human Services highlighted victories and the negotiation of more than $2.3 billion in health care fraud judgments and settlements in fiscal 2018, all of which was repaid to the federal government or private persons. Of that amount, $1.2 billion went to trust funds for the Medicare program. The OIG said federal prosecutors had opened nearly 1,200 criminal health care fraud investigations during that time, which led to more than 570 cases, naming more than 870 defendants. Another 918 civil health care fraud cases also were opened in FY 2018, and the OIG said the sequester had removed $20 million from federal enforcement funds for health care fraud.
The Office of Inspector General (OIG) published a fraud alert regarding genetic testing scams targeting Medicare beneficiaries for the purposes of obtaining beneficiary information. The OIG said the scams typically involve obtaining cheek swabs of beneficiaries as a pretext for obtaining the beneficiary's information.
IBM, of Armonk, N.Y., said in comments to the docket for the U.S. FDA artificial intelligence (AI) discussion draft that public trust in AI will revolve in large part around disclosure of the entities responsible for training an application of AI as well as the data and other information that went into the AI. Director of Technology Policy Roslyn Docktor said the company's AI Fairness 360 program assists users in assessing bias and promotes transparency, a paradigm Docktor said the agency could use to make the needed disclosures without requiring the developer to fully disclose the algorithm to outside parties. She noted that the company urges the agency to "continue to advance a tailored, precision-based approach that can foster a regulatory environment that encourages AI innovation while maintaining the appropriate level of oversight."