2023, Diagnosis, Patient-Centered and Provider

AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog

OCTOBER 16, 2023

discusses several approaches that companies are exploring for use of AI in the diagnosis of Alzheimer’s Disease, including AI-enabled software for retinal scans and identification of genetic triggers. The first article—“Is the Eye the Window to Alzheimer’s?”—discusses Meanwhile, FDA’s AI/ML-focused initiatives continue to expand.

Medical

Medical Patient-Centered Healthcare Specialization

AMPLIFY™ Technology Enhances Prenatal Screening for 22q11.2 Microdeletion

Myriad Genetics

APRIL 15, 2024

4 In a recent presentation, Dale Muzzey, PhD, Chief Scientific Officer at Myriad, summarized the findings this way: “We followed up with providers regarding their patients who screened positive for 22q. 5 Clear Benefits for Healthcare Providers and Patients The benefits to a high PPV are, well, myriad. Prenatal Diagnosis.

Screening

Screening Patient-Centered Diagnosis Healthcare

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). By Larry K. Complaint ¶ 57. (The

Treatment Plan

Treatment Plan ER Government Patient-Centered

The Mycoplasma Comeback: Why This Atypical Pneumonia is Back – A PEMCurrents Podcast

PEMBlog

MARCH 4, 2025

Learning Objectives Describe the clinical presentation, epidemiology, and complications of Mycoplasma pneumoniae infections in pediatric patients, including its atypical manifestations. Laboratory diagnosis and treatment of Mycoplasma pneumoniae infection in children: a review. Pediatr Emerg Care. 2025 Feb 17. doi: 10.1097/PEC.0000000000003338.

Patient-Centered

Patient-Centered Diagnosis Complication Community

Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law Blog

OCTOBER 6, 2023

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

Provider

Provider Manufacturing IT Medical

Parvo Podcast! Erythema Infectiosum, Fifth Disease, and more!

PEMBlog

MAY 1, 2025

Learning Objectives Describe the classic and atypical clinical presentations of Parvovirus B19 infection in pediatric patients, including erythema infectiosum, arthropathy, transient aplastic crisis, and chronic anemia in immunocompromised hosts. Clinical Manifestations and Diagnosis of Parvovirus B19 Infection. UpToDate , Jun.

Complication

Complication Patient-Centered Patients Clinic

Beyond the Diagnosis: A Detailed Characterization of Outpatient Palliative Care Patients [Palliative and end-of-life care]

Annals of Family Medicine

NOVEMBER 20, 2024

Context Palliative medicine focuses on quality of life for patients with serious illnesses. Historically, palliative care has been predominantly provided in the inpatient setting, but there is a growing awareness that patients may also benefit from outpatient care. Results The patients in the SMC had a mean age of 71.

Patients

Patients Diagnosis Patient-Centered Utilities

What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers

FDA Law Blog

MARCH 13, 2023

Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). The meeting will take place virtually on April 13, 2023, from 11:00 AM to 3:00 PM ET. By Larry J.

Patients

Patients Patient-Centered Families Family

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K. HHS forwards FDA’s analysis and recommendation to DEA.

Medical

Medical Physicals IT Healthcare Professional

Amyloid Antibodies and the Role of the Geriatrician: Nate Chin, Sharon Brangman, and Jason Karlawish

GeriPal

AUGUST 17, 2023

The outlook on amyloid antibodies are looking brighter though in 2023. However, as noted in our editorial published with the donanemab trial , the modest benefits of amyloid antibodies would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low risk, inexpensive, and simple to administer.

Patient-Centered

Patient-Centered IT Clinic Patients

What can we learn from simulations? Amber Barnato

GeriPal

FEBRUARY 9, 2023

For example, we spend the first half talking about a RCT simulation study of clinician verbal and non-verbal communication with a seriously ill patient with cancer. In one room the physician under study interacts with a white patient-actor, and in another room interacts with a Black patient-actor. Alex: That’s great.

Patient-Centered

Patient-Centered Patients IT Healthcare

Guiding an Improved Dementia Experience (GUIDE) Model: A Podcast with Malaz Boustani and Diane Ty

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.”

Patient-Centered

Patient-Centered IT Families Family

Hospital-at-Home: Bruce Leff and Tacara Soones

GeriPal

SEPTEMBER 14, 2023

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. JAGS Hospital-at-Home Interventions vs In-Hospital Stay for Patients With Chronic Disease Who Present to the Emergency Department: A Systematic Review and Meta-analysis.

Hospital

Hospital Patient-Centered Supply Chain IT

Trump Whacks Agency That Makes the Nation’s Health Care Safer

Physicians News Digest

APRIL 3, 2025

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.

Patient-Centered

Patient-Centered Hospital Diagnose Medical

Primary Care Digest

AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

AMPLIFY™ Technology Enhances Prenatal Screening for 22q11.2 Microdeletion

Trending Sources

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

The Mycoplasma Comeback: Why This Atypical Pneumonia is Back – A PEMCurrents Podcast

Proposed LDT Rule Raises Many Questions but Provides Few Answers

Parvo Podcast! Erythema Infectiosum, Fifth Disease, and more!

Beyond the Diagnosis: A Detailed Characterization of Outpatient Palliative Care Patients [Palliative and end-of-life care]

What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

Amyloid Antibodies and the Role of the Geriatrician: Nate Chin, Sharon Brangman, and Jason Karlawish

What can we learn from simulations? Amber Barnato

Guiding an Improved Dementia Experience (GUIDE) Model: A Podcast with Malaz Boustani and Diane Ty

Hospital-at-Home: Bruce Leff and Tacara Soones

Trump Whacks Agency That Makes the Nation’s Health Care Safer

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