FDA Pre-Cert, reduction in HACs, and telehealth regulations
In the US-Mexico-Canada Agreement (USMCA), the countries committed to avoid duplicative regulatory requirements and coordinate efforts to harmonize regulations with international fora. There was a commitment to providing a more transparent regulatory framework for exporters including proper classification of devices focusing on safety; prohibition of release of sale, pricing, or financial data used in marketing for the device; and a mechanism for improperly labeled devices to be re-labeled at the port of entry rather than being returned to the exporter.
FDA is proposing a regulatory framework whereby implementation of the Pre-Cert pilot program will occur via the agency’s De Novo premarket pathway in order to establish elements of an effective regulatory model for qualifying SaMD products. Version 1.0 of the Pre-Cert working model includes additions and clarifications covering areas such as the program’s Total Product Lifecycle approach; Excellence Appraisal level descriptions; premarket review pathway determinations; and streamlined Pre-Cert review elements and processes. FDA has also developed a Pre-Cert test plan in 2019 before fully establishing the program as an alternative US market pathway for qualifying SaMD products.
FDA final guidance sets the stage for how the agency intends to make the voluntary option for 510(k) clearance the main pathway for medical device regulatory reviews. The agency will develop performance criteria for each eligible device type deemed appropriate for the alternative option to demonstrating substantial equivalence. It intends to identify these criteria by evaluating the criteria and performance of devices submitted in previous 510(k) submissions or by using existing consensus standards for a particular device type.
Through the use of an Apple Watch, the Attain app gives Aetna members the ability to set health goals, track activity and progress, and provides personalized healthcare recommendations. In the announcement Aetna emphasized the importance of member data privacy and security.
The Agency for Healthcare Research and Quality reported a decline in hospital-acquired conditions such as adverse drug events and healthcare-associated infections between 2014 and 2017. The agency estimated a $7.7 billion savings in health care costs during the time period. CMS credits the reductions to quality and hospital safety initiatives. Pressure ulcers remain a challenge in hospital safety with a 6% increase between 2014 and 2017.
A recent survey, conducted by the Center for Connect Health Policy, found little pattern or coordination for state telemedicine and telehealth guidelines for physical and occupational therapists. The study described a confusing landscape for how telemedicine and telehealth guidelines are being developed.
(mHealth Intelligence 1/23/2019)
Analysis on the first two years of the comprehensive joint replacement model shows modest reduction in cost to Medicare, but no increase in complication rates or joint-replacement procedures performed in high-risk patients. The cost reduction is mainly from fewer episodes discharged to post-acute care facilities.
PDAC has transitioned to Palmetto GBA for the new DMEPOS support contractor as of January 15.
The partnership will combine Microsoft’s cloud and AI platform Azure with Walgreens’ outpatient healthcare and retail footprint. In 2019, Walgreens will pilot up to 12 store-in-store “digital health corners” to sell certain healthcare-related hardware and devices. Among the first projects they expect to tackle is connecting Walgreens stores’ health information to consumers through their digital devices. It will also allow them to harvest insights based on data science and AI.
MediPines Announces FDA Clearance of Breakthrough Respiratory Device, the MediPines Gas Exchange Monitor
MediPines has received FDA 510(k) market clearance on its new non-invasive medical device, the MediPines Gas Exchange Monitor, which provides clinicians with real-time pulmonary parameters and insights to support rapid triage and treatment decisions for respiratory conditions. The MediPines Gas Exchange Monitor provides critical parameters including respiratory rate, oxygen saturation, pulse rate, respiratory quotient and end-tidal CO2. It is the only device that provides novel indices such as oxygen deficit, conveniently packaged in a single, portable, light weight device.
The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, Simbex Research Engineer and Cassie Brugger, MA, Simbex Centers Senior Program Administrator. A story’s inclusion does not imply endorsement by Simbex, LLC.