On June 1, 2021, the Department of Health and Human Services (HHS) announced the formation of a partnership between HHS's Biomedical Advanced Research and Development Authority (BARDA) and the Global Health Investment Corporation (GHIC). GHIC is a nonprofit organization which is the managing member of the Global Health Investment Fund (GHIF). According to its website, GHIF is a $108 million social impact investment fund that supports innovations for public health based on improving or expanding access to existing products. It prioritizes opportunities with "dual market" potential, that will both improve public health in developing countries but will have commercial value in high-income countries. Through its BARDA Ventures program, BARDA intends to provide GHIC with at least $50 million over five years with potential for up to $500 million over ten years, to be part of a global health security fund with matching capital from other investors.
The partnership will be supported by BARDA's Division of Research, Innovation and Ventures (DRIVe), which was launched in 2018. DRIVe currently partners with 37 companies through federal contracts and has a network of 13 accelerators that support early-stage companies, including 154 health security product developers.
- Published: 02 June 2021 02 June 2021
Doximity, Inc. filed a registration statement with the Securities & Exchange Commission on May 28, 2021 for its initial public offering (IPO). The number of Class A shares to be sold and price of shares is not yet specified. The statement specifies that up to 15% of the shares will be reserved for sale to certain qualifying member physicians. The existing Class B shares are held by the company's officers and directors and their affiliates.
Doximity had 1.8 million medical professional members as of March 31, 2021, including more than 80% of US physicians. It also counts 50% of nurse practitioners and physician assistants among its members, as well as 90% of graduating U.S. medical students. Doximity membership is free for physicians; its revenue-generating customers are pharmaceutical manufacturers and health care systems. Doximity states that its cloud-based platform provides tools to its professional members including member profiles for the largest medical professional network in the nation; a newsfeed oriented to the latest medical news; and clinical workflow tools including telehealth, secure messaging and digital faxing. It monetizes its platform through its marketing solutions for pharmaceutical manufacturers and health system customers; hiring solutions for health system customers; and telehealth solutions. With regard to telehealth, Doximity states that it had 63 million telehealth visits in its fiscal year ending March 31, 2021, and subscription agreements with 150 health systems.
- Published: 01 June 2021 01 June 2021
The Food and Drug Administration (FDA) will issue a guidance document on May 20, 2021, regarding non-clinical testing and clinical considerations regarding brain-computer interface (BCI) devices. Implanted BCI devices are neuroprostheses that interface with the patient's nervous system to restore lost motor and/or sensory capabilities for patients with paralysis or amputation. The guidance document is a leapfrog guidance, intended to share initial thoughts regarding emerging technologies early in product development, and is nonbinding.
The guidance document describes information that should be included in submission for an investigational device exemption (IDE). Along with detailed technical specifications, the FDA recommends that the applicant submit risk analysis detailing potential hazards of the device from the perspective of the user; description of the software and hardware supporting operation of the device, including information on cybersecurity aspects; and potential use-related hazards that could result from the user interface design.
The guidance document also includes comment on clinical study considerations. It states that implanted BCI devices are likely to be significant risk devices subject to all requirements of the IDE regulation. The guidance suggests design components which should be considered when developing the clinical study protocol, including implications relating to studying BCI devices in realistic home use environments that may require assessing caregiver safety and what training caregivers will require to assist the patient. The FDA recommends a long-term follow-up period of at least a year, due to the current lack of data on long-term effectiveness of implanted electrodes. Also, in addition to safety endpoints and effectiveness endpoints, patient input may be an important factor in evaluating the device. This would include patient preference information (such as whether the device is comfortable and user friendly) and patient-reported outcomes, such as pain reduction.
- Published: 19 May 2021 19 May 2021
The Centers for Medicare & Medicaid Services (CMS) published a final rule on May 18, 2021, delaying for a second time the rule on Medicare coverage of innovative technology (MCIT) and definition of "reasonable and necessary". The original rule, published on January 14, 2021, was delayed until March 17, 2021 by an interim final rule. It is now delayed until December 15, 2021.
- Published: 18 May 2021 18 May 2021
- CMS delays rule on covering breakthrough devices until December 15, 2021
- Doximity files registration statement for IPO
- FDA to issue leapfrog guidance on brain-computer interface devices
- HHS launches public-private venture capital partnership
- ONC publishes Health IT Standards Bulletin addressing race and ethnicity