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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

A typical individual EHR may include a patient’s medical history, diagnoses, treatment plans, immunization dates, allergies, radiology images, pharmacy records, and laboratory and test results. Is the product “software” according to the definition of MDCG 2019-11? Is the product “software” according to the definition of MDCG 2019-11?

article thumbnail

Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

A typical individual EHR may include a patient’s medical history, diagnoses, treatment plans, immunization dates, allergies, radiology images, pharmacy records, and laboratory and test results. Is the product “software” according to the definition of MDCG 2019-11? Is the product “software” according to the definition of MDCG 2019-11?