Mobile Medical Applications for Devices: Trends, Bills and Guidance

Why Should You Attend:

This webinar will begin with an overview of mobile applications in the health industry, and focus on medical devices related to mobile health. It will then review the new and expected regulations - the 2011 FDA draft guidance in mobile medical apps and the FDA Safety and Innovation Act - and discuss their effects on the use of mobile medical application for devices. We will explain what the policies are, predict coming regulations and discuss how industry will be affected. We will explore the current mobile health landscape in US and globally.

All functional groups who have medical device responsibility or need to understand the basics of mobile medical applications for medical devices and smartphones will benefit by attending this training.

Areas Covered in the Seminar:

• Overview of Health IT and mobile industry.
• Basic of mobile applications for health.
• Medical devices related to mobile health.
• Draft guidances in mobile medical apps(FDA 2011).
• FDA Safety & Innovation Act confirms role in mobile field.
• Patient and Consumer health information and security.
• Coming FDA final guidelines and DHHS actions.
• Mobile health standards.
• Mobile Health globally(WHO).

Who Will Benefit:

• Senior Management
• New medical devices project leaders & members
• Regulatory affairs
• Quality systems personnel
• R&D and engineering staff
• Information Security Officers
• Risk Managers
• Compliance Officers
• Privacy Officers
• Health Information Managers
• Information Technology Managers
• Medical Office Managers
• Systems Managers
• Legal Counsel
• Operations Directors
• Medical offices, hospitals, academic medical centers, insurers, business associate
• All related to risk analysis / management, regulatory submissions, and validations

Instructor Profile:

Dr. Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, is Biomedical/Health Information Advisor, Author & Strategist. Dr. Makrodimitris is the principal for K Makrodimitris that specializes in Health IT business development, eHealth education and social media, Health Information policy analysis. He is certified on EHR/PHR, Business Architecture, Clinical Trials, Biotech/Drug Development, and trained in FDA laws and regulations for different products(devices, foods, drugs).

He is involved as

• Medical Devices Committee Member, Writer at The Food and Drug Law Institute,
• Consultant (Health Informatics/Policies/Standards) at DHS/ONC/HIT, Standards & Interoperability Framework, Health Information Management Systems Society, Health Level 7
• Nifty-Fifty Nominee nationwide, Speaker, Volunteer at USA Science Festival

His multifaceted area of work is in health technology, architecture, policy and decision making.

• In academia (Johns Hopkins, University of Virginia), Kosta researched and published articles in archival journals concerning biomedical and chemical informatics
• In industry (FannieMae, Sysco, MakronanoKosmos), Kosta designed systems, managed analytics projects, cofounded eHealth business contributing to health, marketing solutions.
• In government (US-FDA/DHHS Commissioner's Fellow), Kosta trained and worked in regulatory science, enterprise architecture, standards, and policy, decisions in public health

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