STLR Link Roundup – February 8, 2019

Progress in Pharmaceutical Pricing via Rebates

On January 31st, 2019, the Office of the Inspector General and Department of Health and Human services proposed a rule to lower prescription drug prices by removing the safe harbor under the Anti-Kickback statutes of rebates paid by manufacturers to pharmacy benefit managers, part D plans, and Medicaid managed care organizations. It creates a new safe harbor for discounts that are offered directly to patients and fixed fee service arrangements between manufacturers and pharmacy benefit managers. Rebates pose a strong incentive for drug manufacturers to keep raising list prices and lead to the lack of transparency in drug pricing. Therefore, it is anticipated that this new rule will lead to great benefits in lowering cost, especially among seniors with high drug costs.

Smart-Tech at Border Raises Privacy Issues

House Democrats recently released their proposal for border security. Suggestions include imaging technology for scanning vehicles for drugs and other contraband, as well as “new technology to improve situational awareness.” Exactly how these relatively vague suggestions will be implemented has not been specified. However, certain groups such as Fight for the Future, the Electronic Frontier Foundation, and the American Civil Liberties Union have opposed such measures, suggesting that these suggestions pave the way for technology such as facial surveillance and automatic license plate collection that would infringe upon the liberties of those who live near and pass through the border. The groups have suggested that the implementation of technology at the border has the potential to exacerbate racial inequity when it comes to policing. These technological measures are being suggested as an alternative to a physical border.

Justice Department Sues Opioid Safe Injection House

Philadelphia-based Safehouse, an overdose prevention site, was opened last year in order to provide a medically supervised location for injections. However, U.S. Attorney William McSwain has now filed suit against the organization. The suit is a civil, rather than a criminal, complaint. McSwain alleges that such a consumption site would violate the Controlled Substances Act, and states, “Normalizing use of deadly drugs like heroin and fentanyl is not the answer to solving the opioid epidemic.” On the other hand, supporters of such sites claim that Congress did not intend the Controlled Substances Act to target sites that exist for public health reasons.

No Actual Harm Needed to Sue Under Illinois Biometric Privacy Statute

An Illinois Supreme Court stated in the case Rosenbach v. Six Flags that no actual injury was necessary in order for a plaintiff to sue under the Illinois Biometric Information Privacy Act (BIPA). Under the BIPA, companies must retain consent and inform users as to how they are using biometric identifiers. The case arose when Six Flags collected the plaintiff’s teenage son’s thumbprint for a season pass.  

FDA’s Sentinel System and Big Data

Originally launched in May of 2008, the Sentinel system is used for reporting information about FDA-regulated drugs, vaccines, biologics, and medical devices. However, full implementation of the system was only launched in 2016. Data from partner institutions along with methods such as machine learning and natural language processing is being used to track outcomes such as allergic reactions to certain medications. Earlier this year, the FDA announced a five-year initiative to continue to develop Sentinel. Goals include increasing the user base, enhancing the infrastructure of the system, and disseminating knowledge to outside the agency. Notably, the goals also include utilizing advances in data science and signal detection capabilities for more accurate results.

Google Hit with $57M GDPR Fine

Google is one the first big tech giants to be fined under Europe’s new data privacy laws. The French regulator that imposed the fine, CNIL, found that Google’s policies regarding why data was processed, how long it was stored, what categories were being recorded were difficult to discern and the policies were scattered among various documents. This lack of transparency was said to violate the GDPR. In addition, CNIL found Google’s consent policies non-compliant with the GDPR as well, specifically practices such as bundling consent with the creation of an account and broad “checkbox” consents.

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