Interoperability’s Role in Striving for Precision Medicine
Martha Koroshetz President Obama announced the Precision Medicine Initiative in his 2015 State of the Union address, a research effort to find treatments that are tailored to specific genetic profiles and characteristics. This personalized and context-specific treatment approach will require big data analysis of patient outcomes and their genetic sequence, which must then be accessible and comprehensible to caregivers. The initiative must therefore be able to reconcile genetic data, demographic information, and health information, in the electronic health record. To achieve data interoperability, the organizations engaged in the initiative must confront questions of data privacy, standardize data exchange, and incentivize...
Data Exclusivity for Biologic Drugs: The TPP’s Potential Poison Pill?
Tina Cheung On October 5, 2015, after many years of secretive negotiations, the US government with 11 other countries across the Asia Pacific and Latin America reached an agreement on the largest free-trade deal in history, the Trans-Pacific Partnership (TPP). Addressing everything from wildlife conservation and tax reductions for agriculture, to the free flow of information on the Internet and intellectual-property rights for movies and pharmaceutical drugs, this far-reaching agreement has the potential to impact up to one-third of world trade. One of the most contentious parts of the agreement involves intellectual property rights of pharma companies to data exclusivity...
Keep an I on the Sky: E-Discovery Risks Forecasted for Apple’s iCloud
Daniel Carmeli Some things have not changed since the fire of March 14, 1873. The competing interests of clients seeking convenient storage on one side against providers seeking protection from liability on the other continue to pervade the legal landscape. Naturally, some things have changed, such as the items being stored, the nature of the storage facilities, the associated risks, and the rules governing preservation obligations. Physical property has been replaced with electronically stored information (“ESI”) and warehouses now take the form of remote data servers. And in addition to longstanding conventional risks, such as accidental fire, companies now face...