HB Litigation News

Tag: Life Sciences

  • Oracle Health Sciences on Pharmacovigilance and Artificial Intelligence

    “The potential to use artificial intelligence methods increasingly for the analysis of the increasing amounts of pharmacovigilance data is well understood and many companies are moving (or planning to move) there, and we can predict that routine tasks in pharmacovigilance will in the future be increasingly automated. It will be crucial, however, for regulatory authorities to very clearly provide a position about the use of AI as well as the acceptable level of quality from AI applications. But in parallel with the shaping of those definitions, given the massive increase in their AE case workloads that most companies are currently experiencing, the industry will out of necessity proceed swiftly with the adoption of AI and cloud technologies to reduce their costs and increase their efficiencies.

    “Like other industries, the pharmaceutical business and in particular the pharmacovigilance field will see a massive change in their processes in the near future, away from tedious, repetitive manual tasks towards a better utilization of scarce resources, in particular medical and scientific knowledge, for value-adding tasks. It is imperative for all stakeholders – industry, service providers and regulators – to provide an environment in which such a transformation can take place without ever compromising public health or the safety of the individual patient, and ideally providing additional benefit for patients.”

    A quote from
    Addressing the Data Challenges of Pharmacovigilance

    Download the paper from Oracle Health Sciences

    We are covering this subject at:

    Drug & Device Defense Forum | Oct. 15, 2018 | New York

  • Artificial Intelligence in the Drug and Device Industries

    Are Data Divers and Miners Going to Lead Innovation?

    The big tech companies are into it. Apple, IBM and Google. Roche is into it. Medtronic, as well. Artificial intelligence has been a big part of innovation in the healthcare space for several years, and its impact is only going to get bigger.

    “Artificial intelligence-based healthcare technologies have contributed to improved drug discoveries, tumor identification, diagnosis, risk assessments, electronic health records (EHR), and mental health tools, among others,” writes Blank Rome attorney Brian Higgins in his Artificial Intelligence and the Law Blog (it’s excellent, by the way).  [1]

    Daniel Faggella of TechEmergence.com writes that machine learning healthcare applications are getting a lot of attention in the press and from the investment community. He adds to the list of machine learning’s impact things like treatment queries and suggestions, and even robotic surgery.

    But optimism for AI’s application to drug discovery seems greater than that inspired by other healthcare sectors. One reason for that, Faggella writes, is that compared to other segments where various laws and stakeholder incentives may not align, “drug discovery stands out as a relatively straightforward economic value for machine learning healthcare application creators.” He adds that this application also involves “one relatively clear customer who happens to generally have deep pockets: drug companies.” [2]

    Also writing for TechEmergence.com, Kumba Sennaa says doctors may feel threatened at the idea of competing with artificial intelligence tools. Not so in the case of drug makers.  “Unlike doctors, pharma companies have every reason in the world to adopt the most cutting-edge technologies in the expensive and lengthy process of drug discovery,” Sennaa writes. “Unlike other applications within healthcare facilities, drug discovery seems to have a clearer path to adoption.” [3]

    AI-fueled innovation is, in turn, fueled by data. Lots and lots of data. “And there is no better place to find big data sets than in the healthcare sector,” Higgins says. “According to an article last year in the New England Journal of Medicine, by 2012 as much as 30% of the world’s stored data was being generated in the healthcare industry.”

    “Thanks in large part to AI and the availability of health-related data,” Higgins says, “health tech is one of the fastest growing segments of healthcare and one of the reasons why the sector ranks highest on many lists.”

    “To be successful,” Higgins predicts, “tomorrow’s healthcare leaders may be those who have access to data that drives innovation in the health tech segment. This may explain why, according to a recent survey, healthcare CIOs whose companies plan spending increases in 2018 indicated that their investments will likely be directed first toward AI and related technologies.”

    Related

    Given the investment and tremendous opportunity AI provides for the drug and device industries, the chairs of our Fifth Annual Drug & Device Forum are developing a session on the subject. Join us for this and discussion of other important topics on Oct. 15, 2018 in New York.

    If you have ideas please reach out to one of our chairs directly or via Ideas@LitigationConferences.com. They are Megan Grossman of Segal McCambridge Singer & Mahoney, Michelle Hart Yeary of Dechert, and Jim Frederick of Goodell DeVries Leech & Dann. Learn more. 

    Also, on Sept. 27 we are co-producing a webinar titled A.I. Best Practices: Rules and Policies for Using Artificial Intelligence in Your Business. The webinar features John Weaver of the McClane Middleton law firm and contributing author to the Journal of Robotics, Artificial Intelligence & Law. We are producing this in collaboration with growing legal research company Fastcase. Learn more.

    Links to the articles cited in this post:

    #1. http://aitechnologylaw.com/2018/03/data-driven-health-tech-innovation/

    #2.  https://www.techemergence.com/machine-learning-healthcare-applications/

    #3. https://www.techemergence.com/ai-in-pharma-and-biomedicine/