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HHS Clarifies HIPAA Liability for EHR System Developers that Transfer Data to Health Apps

On Friday, April 19, 2019, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) explained in an FAQ the circumstances under which electronic health record (EHR) systems may be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) liability for an app’s impermissible use or disclosure … Continue Reading

CFDA Releases Draft Classification Catalogue of Medical Devices

The China Food and Drug Administration (CFDA) has recently released a long-anticipated draft Classification Catalogue of Medical Devices (Draft Catalogue). The Draft Catalogue updates a 2002 Classification Catalogue (Current Catalogue) and is one of the final pieces in the reform of China’s medical device system that has taken place since the 2014 revision of the … Continue Reading

FDA Releases Draft Guidance on IDE Device Categorization to Assist CMS Coverage Decisionmaking

Last week, the FDA issued draft guidance modifying its current policy on categorizing Investigational Device Exemption (“IDE”) devices, in support of the Centers for Medicare & Medicaid Services’ (“CMS’s”) Medicare coverage decisions.  The guidance is intended to implement a Memorandum of Understanding (“MOU”) between the agencies to streamline and facilitate efficient categorization.  FDA requested that … Continue Reading

The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests Convenes its Inaugural Meeting

On August 26, 2015, the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (hereinafter the “Panel”) held its inaugural meeting.  The Panel was established by the Secretary of Health and Human Services under the authority of Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which prescribes a new market-based payment system … Continue Reading

FDA is Examining Device Risk Assessments in Postmarket Settings

On March 19, 2015, FDA published a public workshop notice entitled “An Interactive Discussion on the Clinical Considerations of Risk in the Postmarket Environment.” This meeting is being held on April 21 in order for FDA to further engage with the medical device industry on “assessing changes in medical device risk as quality and safety situations arise … Continue Reading