MedTech Insider:  FDA Releases Mid-Year Pre-Cert Update

MedTech Insider: FDA Releases Mid-Year Pre-Cert Update

- July 26, 2019


FDA Releases Mid-Year Pre-Cert Update

The Federal Drug Administration has released a mid-year update on its digital health pre-certification pilot program. Currently, the original 9 companies allowed are enrolled within the new Working Model format, meaning that additional companies seeking approval on new products will no go through the new Pre-Cert pathway in addition to the traditional review process. Unlike previous FDA regulatory processes, the Pre-Cert program will provide approval focus on companies and developers as opposed to individual products. As part of the program, the FDA will complete retrospective testing in which the agency developed a mock excellence appraisal summary based upon the pilot participant site visits and public comments. Reviewers additionally completed a mock assessment to determine if a regulatory decision could be made on the excellence appraisal summary. In the update, the agency remarked that, “The test achieved its objectives in identifying the feasibility of the Streamlined Review package along with the Excellence Appraisal summary to be sufficient to conduct a premarket review of SaMD [software as a medical device].”  If finalized, the Pre-Cert program could drastically alter the way digital health companies interact with the FDA.  


Healthcare Industry Experiences Unprecedented Rates in Data Breaches

For the ninth consecutive year, the healthcare industry has experienced the highest cost of  data breaches. According to recent findings from the “Cost of a Data Breach Report” completed by IBM Security and Ponem Institute, the rise in data breaches have cost organizations nearly $6.3 million on average, more than 60 percent higher than any other industry. In a comment to Healthcare IT news, Chief Technology Officer and Global Remediate Lead at IBM X-Force IRIS explained the vulnerability of patient data: “Unlike passwords that can be changed or credit cards that can be reset with an expiration date, health data lasts forever and can be used for numerous malicious activities such as identity theft, insurance and health care fraud, and more.” Scott, as well as other security experts, shared that one critical area of improvement for healthcare organizations would be the adoption of security automation tools.


Tension Rises Between Amazon’s Pill Pack and Surescripts

A year after acquiring the online pharmacy company PillPack for $753 million, Amazon is involved in a tense battle with incumbent industry player Surescipts over access to patient data. PillPack’s current online pharmacy service depends on comprehensive patient medications lists provided indirectly from Surescripts in order to inform patients on health and safety risks, and help them keep up with refills. PillPack now says that access to this vital patient data will soon be cut off: “While we’re not surprised when powerful incumbents try to undermine these efforts, we are confident that our collaborative approach to bring customers more choice, more convenience, and improved quality will ultimately prevail.” Amazon is now considering legal action again the CVS owned company. The conflict follows a recent lawsuit filed by the FTC alleging that Surescripts is “illegally monopolizing the e-prescribing market.”


CVS Health Launch Social Care Network

CVS Health will be launches a social care network platform aimed at addressed social determinants of health as insurers develop strategies to integrate beyond doctor’s offices and into communities in order to reduce medical costs. CVS and its Aetna health insurance will reportedly partner with Unite Us, a “social care coordination platform.” The social care platform comes alongside an wide host of initiatives intended to address various social determinants of health in order to cut health care costs including a $40 million investments from CVS and Aetna in affordable housing. In a released statement, Taylor Justice, Co-Founder and President of Unite Us, remarked: “Our mission is to connect individuals and families across the United States to the services they need through collaboration with local service providers, shared infrastructure, and an inclusive approach for those in need.”



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