Kosta Makrodimitris
Instructor Kosta Makrodimitris
Product Id 600942
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Mobile Medical Applications: Trends and Regulations in US & Globally

Overview:

m-Health is the field of using mobile devices to provide services and support for medicine, healthcare and public health. It’s a fast growing field globally that targets doctors, patients, consumers, managers and IT groups among others. The trends for this field are showing a lot of investments and high revenues for the coming years.

Several government agencies in US (FDA, FTC, FCC, ONC) and worldwide are preparing guidances and regulations to protect patient safety and privacy of health information. In addition there are other standards development organizations who try to harmonize efforts globally to propose mHealth standards for new mobile health systems. The topic and the field of m-Health and mobile medical applications is multidisciplinary since multiple stakeholders are involved and have a lot of interests.

Why Should You Attend: This webinar will provide the new and expected regulations and discuss their effects on the use of mobile medical application for devices. We will explain the policies, predict coming regulations and discuss how mobile Health (m-Health) industry will be affected. We will explore the current emerging m-Health landscape in US and globally.

All functional groups who have responsibility or need to understand the new technologies and regulations of mobile medical applications and biomedical software for medical devices and smartphones should attend.

Areas Covered in the Session:

  • 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 2011-2012)
  • FDA Safety & Innovation Act and m-Health
  • Patient and Consumer health information and security
  • Coming FDA final guidelines and DHHS actions
  • Mobile health standards
  • Mobile Health globally(WHO, EU)
  • Future of m-Health industry and workforce

Who Will Benefit:
  • Management
  • Health IT Managers
  • Research and Development
  • Regulatory Affairs Personnel
  • Quality assurance/quality Control Personnel
  • Auditors and Inspectors
  • Entrepreneurs
  • Investors

Speaker Profile
Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, is Biomedical/Health Informatics Advisor, Author & Strategist.

Dr. Makrodimitris is the principal for K Makrodimitris that specializes in Health IT & BIO business development, eHealth education, Health Information policy.

He is certified on EHR/PHR, Clinical Trials, Biotech/Drug Development, and trained in US FDA/DHHS laws, regulations (devices, foods, drugs, personalized health). He is involved as, Medical Devices Committee Member, Writer at The Food and Drug Law Institute, Consultant (Health Informatics/Policies/Standards) at DHHS/ONC, Standards & Interoperability Health Information Management Systems Society, Health Level 7(EHR, Genomics, mHealth) , small businesses, 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 solutions (foods, health, finance).

In government (US-FDA/DHHS Commissioner's Fellow), he worked in regulatory science, enterprise architecture, standards & policy in public health. In MD State he was program manager for BIO-economic development.

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