SQA

FEBRUARY 15, 2023

cloud services) are also to go into more detail and the meaning of “validation and qualification of the systems” is to be clarified in greater depth. A new focus is to be on data integrity, in particular the requirements for “data in motion,” and data in archives or in backup, the so called “data at rest.”

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Health Populi

JANUARY 2, 2020

Hearables have been emerging at CES for a few years, and now vision will be a newer category to watch. (As At CES 2013, David Van Sickle, CEO and founder of Asthmapolis, spoke in a CES keynote panel about the usefulness of health data in the cloud. Forbes ran a column on CES 2020 discussing AI in hearing and vision.

FDA 124

FDA Public Health Telemedicine 124

Health Populi

JULY 1, 2019

Get a cup of coffee and sit back, because this is a long one – not the usual short and sweet entry that each of us endeavors to craft on our respective blogs. These are: Perception, Trust, Risk and the Uncertainty Produced by an Ever-Changing Context, categories that sweep in all of the issues at hand.

Health Insurance 86

Health Insurance Pharmaceutical Industry HIPAA Bioethics 86

Total HIPAA

FEBRUARY 1, 2021

Potential Business Associates are people or companies like: Accounting or consulting firms Cloud vendors Consultants hired to conduct audits, perform coding reviews, etc. The BA and BAS Agreements are almost identical, so the primary difference is the definition of the category. Who is not considered a Business Associate/Subcontractor?

HIPAA 52

HIPAA Compliance 52

HIT Consultant

FEBRUARY 27, 2023

Consider this blog post a guide to everything you need to know about fourth-party vendors and the risks they pose. To accommodate these oceans of paperwork, healthcare organizations began enlisting the services of third-party cloud and SaaS companies. This is a positive development, but it is also insufficient.

Ransomware 97

Ransomware Governance 97

Health Law Advisor

AUGUST 10, 2023

In this blog post, we take on the question of when machine learning software developed by those involved in delivering health care is FDA regulated. Medical Device Data Systems Prior to FDA’s Mobile Medical App Guidance, this topic was addressed by FDA when it created the category of Medical Device Data Systems (“MDDS”). 3] 21 U.S.C.

FDA 98

FDA Licensing Hospitals Medicaid 98

Kaiser Health News

MAY 6, 2022

It would also preclude, he noted in a blog post for Reason magazine , a hypothetical CDC ban on “defecation” on the floor of a bus or airplane, since such a ban “does not clean anything.” “It’s hanging like a black cloud over the CDC. A second, very separate statute could also come into play.

Governance 75

Governance Public Health COVID-19 75

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. A website created. . . April 18, 2000) (in table at 616 N.W.2d Kuali, Inc. ,

Governance 52

Governance Payment Systems Hospitals Licensing 52