Lidia Niecko-Najjum

Lidia Niecko-Najjum

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Latest Posts › 21st Century Cures Initiative

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Health Care Industry Must be Mindful of ‘Information Blocking’

Under the 21st Century Cures Act (Cures Act), the Health and Human Services (HHS) Secretary is mandated to have promulgated regulations by Dec. 13, 2017 that, among other requirements, prohibit “information blocking” as a...more

1/4/2018  /  21st Century Cures Initiative , EHR , Electronic Medical Records , Health Care Providers , Health Insurance Portability and Accountability Act (HIPAA) , Information Technology , Medicare Access and CHIP Reauthorization (MACRA)

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

12/19/2017  /  21st Century Cures Initiative , Deregulation , Food and Drug Administration (FDA) , Health Information Technologies , Medical Devices , Pharmaceutical Industry , Regulatory Oversight , Regulatory Reform , Software
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