Patient Centeredness: Definitions Fuzzy,
Testing, Lawsuits Ahead #ECRI_FDA

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Panel #2 –

Lawyers are going to have a field day with what is patient centeredness.

Jane Hyatt Thorpe, JD, Assoc. Research Prof.

ACA – Medicare – care individual/population, average.

IOM – patient centeredness refers to care – needs, desires of patient

another notion: patient experience.

right care, right patient every time — is this something that we can really provide?

Informed consent – case law — what do providers need to give pts. TeachBack type concept. What we are seeing – risks/benefits procedure. Drug use, volume – part. if influence outcomes. Financial disclosures – increasing requirements.

Advanced Directives – convey what their wishes are.

Provider liability – joint role. translate. liability, according to

Rights and responsibilities.

New delivery models – teams of care, focusing on empowering patients. HC law – a lot of policy variation.

Many openings for better definitions.

Michael Park, JD, Counsel, Alston and Bird

“the average patient”

20 quality measures in ACA – overlap with shared savings programs.

evidence towards individual.

Can we define better?

“Consent the patient” — grammar is important, words are important.

too much focus on getting the consent —

FDA only agency in country, no requirement that minorities. Diversity in clinical trials.

Hornbaugh? – Disability – we can’t have patients who can’t travel. should be accommodated. clinical trials


averages used in payment systems reconciling with indvidual in patient centeredness


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