Outgoing FDA head calls for better regulation of EHRs and CMS announces AI Health Outcomes Challenge

 In Blog

Regulatory News

CDRH Qualifies 3rd Medical Device Development Tool

The OsiriX CDE aims to standardize how health care providers, such as neuroradiologists, mark and classify brain contusions using common data element (CDE) criteria, as well as label abnormalities observed in magnetic resonance images. This can inform clinical trial enrollment for the development of a mild TBI device. This marked the first biomarker test to receive qualification.
(RAPS 3/13/19)

Italian medical device nomenclature to be used for Eudamed database

The European Medical Device Coordination Group (MDCG) plans to use Italy’s CND codes as the basis for the Eudamed device database nomenclature. CND codes will be mapped to Global Medical Device Nomenclature (GMDN) for ease of use. MDCG decision stems from requirements in the European Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) that free nomenclature for devices be made available in Eudamed. Global Medical Device Nomenclature (GMDN), currently used worldwide as a nomenclature tool, requires membership fees for access.
(MassDevice 3/14/19)

Report: Outgoing FDA head Gottlieb calls for better regulation of EHRs

Gottlieb said that oversight of electronic health records would require Congress pass legislation defining when EHRs would need regulation, adding that currently digital records systems that store a patient’s medical history don’t fit under the FDA’s regulatory purview. Healthcare IT companies could add new functionality to EHRs that would improve their usefulness, Gottileb said, but companies have been reluctant to do so because it would put their products under FDA jurisdiction.
(MassDevice 3/25/19

FDA to Significantly Update Breast Cancer Screening Methods

The agency has made a proposal to amend regulations issued under the Mammography Quality Standards Act of 1992 (MQSA), which Congress passed to ensure quality mammography for early breast cancer detection. Among the proposed amendments to improve communication and medical decision-making is the addition of breast density information to the mammography lay summary letter provided to patients and to the medical report provided to their referring health care professionals.
(MDDI 3/27/19)

FDA Wants to Take a Hard Look at Medical Device Materials

The statement called for the public, scientists, and industry stakeholders to help FDA determine the current state of the science, critical gaps in the existing science, and what approaches should be considered to further the agency’s understanding of medical device materials in order to improve the safety of devices for patients.
(MDDI 3/15/19)

Industry Calls to Eliminate Tiers in FDA’s Premarket Cybersecurity Guidance

The draft, released in October 2018, created a two-tiered approach to determining cyber risk, with higher risk devices falling into Tier 1 while other devices would be of “Standard Cybersecurity Risk” or Tier 2. AdvaMed, for instance, called for eliminating the tiered approach and said it finds “this proposed two-tier framework confusing and unnecessary given its superficial similarity to FDA’s risk classification scheme for medical devices.”
(RAPS 3/18/19)

CDRH Program Seeks to Resolve 510(k) Issues in New Way

CDRH is implementing the least burdensome flag as a program for 510(k) submissions to act as a performance metric for the implementation of least burdensome requirements. The center had not informed through the traditional channels for such initiatives that it ran a least burdensome flag pilot from February 2018 through September 2018 across seven review branches within ODE. Shuren touted the pilot as an “opportunity for sponsor to ‘throw flag’ during review,” like in the NFL when a coach can throw a flag to question a referee’s call.
(RAPS 3/15/19)

Payment News

DMEPOS Competitive Bidding Round 2021

CMS is consolidating the competitive bidding areas that were included in Round 1 2017. CMS is shifting some items to different, small product categories to accommodate the lead item pricing methodology. Items newly included in DMEPOS Competitive Bidding are off-the-shelf (OTS) back braces, OTS knee braces, and non-invasive ventilators.
(CMS.gov 3/8/19)

Humana launches, expands bundled payments for its Medicare Advantage members

Humana is ramping up its bundled payment programs and expanding existing episode-of-care-based model for THR and TKR procedures. Both programs offer the opportunity for additional payments to physicians and clinicians for improvement in patient health outcomes and lower costs.
(Healthcare Finance 3/19/19)

CMS Launches AI Health Outcomes Challenge to Accelerate Innovation

The AI Health Outcomes Challenge will give innovators a chance to demonstrate how AI tools can be used to forecast unplanned hospital and skilled nursing facility admissions and adverse events.
(MedTech Boston 3/27/19)

Amazon-led healthcare venture has a name and website

The healthcare partnership between Amazon, JPMorgan, and Berkshire Hathway has released new details including a name: Haven. Haven will focus on the 1.2 million employees and families affiliated with the companies.
(Fierce Healthcare 3/6/19)


Reflexion Health’s virtual rehab assistant posts similar results to traditional therapy

Separate studies have found that Reflexion Health’s virtual exercise rehabilitation assistant (VERA) was as safe and effective as traditional physical therapy while saving $2,745 per patient in a bundled-payment setting. Reflexion designed VERA as a digital therapy platform that integrates several components for a comprehensive, home-based rehabilitation experience without the need for patients to apply or wear any sensors or monitoring devices.
(MassDevice 3/13/19)

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.

Recommended Posts

Start typing and press Enter to search