Partner Stephan Rau will be speaking on the latest developments in life sciences regulation at the ABA’s 2018 Life Sciences Conference.
Life science is amongst the fastest growing sectors both economically and technically. It is offering patients new and better treatments through new and evolving technology advancements, including more sophisticated electronic medical records (EMRs), wearable health care devices, next-generation sequencing, breakthroughs in genomics, immunotherapy, and gene therapy, and use of real-world evidence (RWE) and data analytics.
However, this all comes at a cost. The obvious are financial, but as medical devices are increasingly interconnected—via the Internet, hospital networks, other medical devices, smartphones, electronic health records, and third-party cloud solutions—there’s also an increased risk of cybersecurity attacks and infringements of the patients’ personal sphere. This session will give a perspective on the current position and then focus on anticipated legal issues and possible solutions, including data protection issues, intellectual property issues, compliance issues, and whether the regulation and increasing compliance requirements are adequate and can keep up with the tides of change.