The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NICE unimpressed by stenosis measurement software; MedPAC says more study needed for expanded telehealth coverage.
I-O Urology Corp. launched its Carepath platform to provide remote patient monitoring for urologic conditions. The platform uses a compact portable system to capture real-time urine voiding data and a mobile app to facilitate accurate reporting and timely communication between patients and their health care providers.
The Biden administration imposed a regulatory freeze in January, which among other things affected the final rule for the Medicare Coverage of Innovative Technologies (MCIT) program. Despite the freeze, Cybil Roehrenbeck, a partner in the D.C. office of Hogan Lovells US LLP, told BioWorld that this program enjoys broad support in Washington, and thus should survive the new administration’s review of the program under Xavier Becerra, should he be appointed the Secretary of Health and Human Services.
A bad patient experience with telehealth can blunt adoption regardless of the incentives for developers and doctors. Griffin Mulcahey, chief compliance officer at Wheel Health Inc., of Austin, Texas, said during a recent webinar that users of these digital health apps and telemedicine programs may need assistance to get up to speed on an application, a critical effort that may make the difference between success and failure in telehealth.
Several telehealth bills are in circulation on Capitol Hill, but U.S. federal government agencies have expressed concerns about the potential for fraud and abuse, and the impact on Medicare spending. Despite those concerns, two key members of the House Energy and Commerce (E&C) Committee, Reps. Frank Pallone (D-N.J.) and Anna Eshoo (D-Calif.), said during a March 2 hearing that they have misgivings about those cautionary views of telehealth, suggesting that any related legislation will aggressively expand Medicare coverage of telehealth.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CRS: Supply chain for testing still under pressure; AHRQ eyes provider-to-provider telehealth; Health Canada emphasizes nursing homes in report on testing; Advamed, Georgia Bio sound off on EtO.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Neovasc snares second patent term extension; CMS drops CT image quality proposal; TGA opens docket for nanomaterials regulation; ATA supports OIG statement on telehealth.
Withings Health Solutions, the business-to-business division of the connected health company Withings SA, is launching two cellular-connected devices that allow patients to measure their weight and blood pressure at home and immediately transmit the results to a health care provider. The products – the Body Pro smart scale and the BPM Connect Pro at-home blood pressure monitor(BPM) – are being marketed directly to health professionals, as well as researchers and chronic disease management companies, for distribution to patients to use at home.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: White House names pick for CMS administrator’s post; FDA posts advisory for pulse oximetry; CDC: Telehealth visits dropped over last half of 2020; CRS says user fee shares of total review costs on the rise; Federal Circuit kicks case back to PTAB.
BERLIN – The German government has just made $3.6 billion available to the Future of Hospitals Act (Krankenhauszukunftsgesetz, KHZG), through the liquidity reserve of the health fund in order to support public hospitals with digital transformation. Besides this government cash injection, an additional $1.6 billion will be made available through co-funding by the German federal states, the 16 Länder. In total, German hospitals will get a $5.2 billion funding to boost digitization.