COVID-19 is on the verge of becoming a pandemic. Here we highlight Chinese infectious disease management and the regulatory mechanism for clinical diagnostics.
The introduced reimbursement of digital health apps in Germany provides many chances for manufacturers of innovative digital health solutions.
While establishing payment mechanisms is an important part of the DTx value realization chain, creating a clear and differentiated value proposition and an effective value communication strategy are critical, precursive steps to value monetization.
An official statistical report of the 2018 national social health insurance fund, which provides high-level data for an outsider to try to grasp the essential characteristics of China’s healthcare funding and delivery system and understand the challenges an industry player as well as the Chinese government payer are facing...
From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA evaluated a total of 166 Dossiers - 28 were related to orphan drugs, 56 to new active substances, 57 to extensions of indications for drugs already reimbursed, and 25 to other types of negotiations.
The field of DTx has gained traction over the last couple of years, with FDA approvals/clearances, the founding of a DTx specialty society, large-scale acquisitions of DTx firms, pharma investments in DTx, and pharma co-development deals, amongst other key developments.
Press Releases and Publications
Boston Healthcare Presents Key Findings Associated With the Use of an AI-Enabled In Vitro Diagnostic Test
27 March 2020
The Boston Healthcare team presented key findings related to the health economic value associated with the use of an AI-enabled in vitro diagnostic test to identify CKD patients with type 2 diabetes at risk for rapid kidney function decline. BHA’s Senior Vice President, Thomas Goss, made a presentation during the late-breaker session at the National Kidney Foundation Spring Clinical Meeting in March 2020.
Read the article here: https://bit.ly/2UKaJks
View the poster here: https://bit.ly/2UFIx27
Diagnostics Developers Rapidly Utilizing New Payment Codes Established by PAMA
7 November 2018
Access the article from 360Dx here.
Compliance Conundrum: Genomic Health Faces DoJ Investigation after CMS Changes Date of Service Regs
Genomic Health has disclosed that it is the subject of a U.S. Department of Justice investigation into its compliance with changes that took effect in January to Medicare’s Date of Service billing regulation. Adam Crowther, Manager, spoke with Clinical Omics about the impact on diagnostics companies. Access the Article Here.
Medical Device & Diagnostics Industry
Considering Market Access Risk as Part of Today’s M&A Process
In an exclusive published today in Medical Device and Diagnostics Industry, Vice President, Rob Wenthold discusses the key market access issues examined during the M&A process and demonstrates the importance of market access to inform M&A through case studies and business decision-making in general. Read the article here.
Boston Healthcare Adds Seasoned Market Access Leader to Global Life Science Consulting Team.
Cost-Conscious MedSeq Project Provides Snapshot to Suggest Genomic Sequencing does not Increase Downstream Healthcare Costs
CEO, Joseph V. Ferrara commented on the value sequencing might bring to the clinical setting in the May-June 2018 Issue of Clinical Omics. Access the article here.
Global Business Reports
United States Biopharmaceuticals 2018
Thomas F. Goss spoke to Global Business Reports on the US Biopharmaceutical Industry. Read the report here.
Real-World Evidence in the Era of Advanced Diagnostics
Shivang Doshi, Director at Boston Healthcare wrote an op-ed for the March-April edition of Clinical Omics on real-world evidence for advanced diagnostics. Access the article here.
International Regulatory Group Proposes Principles for Evaluating Safety, Performance of Diagnostics
Joseph V. Ferrara, CEO of Boston Healthcare spoke with 360Dx News about the proposed Principles for safety and performance of medical devices, including IVD medical devices, put forward by the International Medical Device Regulators Forum (IMDRF). Read the article here.