FDA proposes framework for AI devices and opportunity for CMS payment increase to breakthrough devices

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Regulatory News

FDA Drafts Guidance on Inspections of Medical Device Establishments
The three-page draft guidance, which satisfies a requirement established by the FDA Reauthorization Act of 2017, provides for standardized communication methods during the inspection process.
(RAPS 3/28/19)

FDA takes steps toward a new, tailored review framework for artificial intelligence-based medical devices
FDA proposed a new regulatory framework specifically tailored to promote the development of safe and effective medical devices that use advanced artificial intelligence algorithms.
(FDA 4/2/19)

WHO Drafts Global Strategy on Digital Health
Strategic objectives include: UN organization working to engage stakeholders on a shared digital health agenda; building digital health capacity along the seven components set forth in WHO’s 2012 National eHealth Strategy Toolkit; and stimulating and supporting country-specific digital health strategies. The lack of metrics to evaluate progress on new initiatives, frameworks and policies also poses a challenge. Actions will take place from 2020 through 2024.
(RAPS 4/8/19)

FDA Expands RWE Demonstration Project
Originally, the demonstration project sought to replicate the results of 30 RCTs, but now the project seeks to identify when and where RWE, based on health care databases, can provide robust estimates of treatment safety and efficacy for supplemental new drug applications. Such findings will lay the groundwork for regulators to gain confidence in their decision making of whether an RCT can be substituted with a RWD study.
(RAPS 4/10/19)

Provider, health IT groups praise proposed bills to change patient privacy regulations
By aligning 42 CFR part 2 with the patient privacy protections currently in place under HIPAA, the medical community will be able to utilize substance use disorder (SUD) treatment records in the same manner as all other medical records. Unfortunately, under current law, SUD treatment and diagnoses are kept confidential from other providers, which can be extremely problematic when a clinician is attempting to treat someone but is unaware of their prior addiction history.
(FierceHealthcare 4/8/19)

Penumbra VR device wins FDA clearance
Penumbra recently received FDA 510(k) clearance for its Real Immersive virtual reality system. The Real Immersive System is an immersive virtual reality and display system that tracks upper extremity rehabilitation exercises for adults who have symptoms related to acute pain, cerebral palsy, stroke, orthopedic or neurodegenerative diseases.
(MassDevice 4/15/19)

Experts Tell Device Companies Not to Fret Over QMS Transition
A new technical information report is underway at the Association for the Advancement of Medical Instrumentation (AAMI) to map the ANSI/AAMI/ISO 13485:2016 and 21 CFR 820 correlation. FDA plans to leverage MDSAP to roll-out the transition prior to nationwide adoption of the harmonized regulation.
(RAPS 4/16/19)

WHO Releases First Guideline on Digital Health Interventions
The focus of the guideline is currently limited to digital health technologies that can be accessed via cellphones, tablets and/or computers and indicated for improving patient health and essential health delivery services. The 10 recommended interventions are deployable via any digital device, which is meant to ensure such interventions are applicable in settings with low resources.
(RAPS 4/17/19)

MedTech Europe Warns Over ‘Untenable’ Transition to EU MDR/IVDR
Notified Bodies (NBs) will typically take 3-9 months to complete a product re-certification, and it is expected that it will take them even more time for new MDR certification. There is a prediction that up to just 12 NBs will be designated by year’s end. This gives no guarantee that NBs would have enough capacity to ensure continued regulatory approval of devices by May 2020.
(RAPS 4/17/19)


Payment News

CMS Plots to Increase Breakthrough Device Payments
CMS has proposed a new rule that would increase payments for medical devices designated by the FDA as breakthrough devices.
(RAPS 4/24/19)

CMS Proposes Measure Pushing Health Data Exchange in Post-Acute Care
Two newly-proposed quality measures from CMS would promote health data exchange in inpatient rehabilitation facilities. The measures seek to address medication accuracy at transfer or discharge.
(EHR Intelligence 4/18/19)

Costs, Reimbursement Impede Hospital Medical Device Adoption says Vizient
A recent paper from Vizient shows that claims reimbursement and costs create tension between providers, supply chain leaders, and revenue cycle managers that impede adoption of new medical devices.
(Rev Cycle Intelligence 4/18/19)


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.

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