The market for direct-to-consumer (“DTC”) genetic testing has increased dramatically over recent years as more people are using at-home DNA tests. The global market for this industry is projected to hit $2.5 billion by 2024. Many consumers subscribe to DTC genetic testing because they can provide insights into genetic backgrounds and ancestry. However, as
On Friday April 26, 2019, the US Department of Health and Human Services (“HHS”) issued a notification regarding HHS’ use of Civil Monetary Penalties (“CMP”) under the Health Insurance Portability and Accountability Act (“HIPAA”) as amended by the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. https://www.federalregister.gov/documents/2019/04/30/2019-08530/enforcement-discretion-regarding-hipaa-civil-money-penalties. The notice provides: “As a…
About a month ago, I had the opportunity to participate at the Inaugural Advances in Clinical Technology conference in London. The conference covered a broad array of topics relating to how technology can and is changing how clinical trials are conducted. Here are the top three things that I took away from the conference.