E-Health and digital health regulatory strategy, classification, trends and challenges2020-08-12T11:41:35+00:00

E-Health and digital health regulatory strategy, classification, trends and challenges

General Information:

Course scope: 18 hours (9:00-17:00)
Course type: Frontal + remote
Location: Science park, Rehovot
Lecturer name: Eran Yona

Medical software, cellular application, telephone / digital medicine, wearable equipment, or any other digital health device used for sensing, monitoring, testing, analyzing, drawing conclusions or supporting medical staff decisions may have an impact on the health of the user and may, therefore, be considered At the regulatory level as a medical device and therefore strict compliance with regulatory requirements.

The various digital health products are divided into categories, depending on the level of risk they represent and hence the regulatory requirements on the subject are also set. In order to obtain the approval of the health authorities, the most appropriate category must be selected, according to which the product will be classified as well as its registration route.

The process of registering a digital health product / digital product requires resources of time, money and knowledge. Therefore, awareness and compliance with regulatory requirements in advance, while understanding the limitations and limitations and preparation of relevant documents ahead of time, can save the company valuable time and unnecessary increases.

Course Content:

  • The Digital Health new era
  • Digital health and E-health technologies and products from various fields
  • What are the relevant questions to be asked as part of the development process?
  • What are the principles for determining the risk level of the product?
  • What questions should be asked to choose the most appropriate regulatory pathway?
  • What should be included in the classification rational?
  • Understand the basic regulatory requirements of each classification
  • What is QMS?
  • Understanding the basic principles of HIPAA and GDPR for patient information confidentiality
  • Risk Assessment
  • Future trends and challenges in the E-health industry

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