Physician's Practice

JUNE 23, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article Navigating the health tech landscape requires strategic diligence to avoid hidden costs and ensure seamless integration in medical practices. The health technology gold rush is back on, and sales reps know where to find you.

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ABIM

MARCH 27, 2025

The American Board of Internal Medicine (ABIM) is committed to enhancing the quality of health care by certifying internists and subspecialists who demonstrate the knowledge, skills and attitudes necessary for excellent patient care.

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Board-Certified Medical Specialty Internal Medicine Education 52

FDA Law Blog

NOVEMBER 29, 2021

Currently, DEA regulations do not address transfer of controlled substance prescriptions — whether paper or electronic — between pharmacies for the initial filling of the prescription. At present, a pharmacy that receives an EPCS that it is unable to fill can only notify the patient that the prescription cannot be filled.

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FDA Law Blog

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Instead, the patient must request that the prescriber send a new prescription to a different pharmacy. By Larry K. 48365, 48369 (July 27, 2023).

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Electronics Patients IT Provider 52

FDA Law Blog

JULY 31, 2023

CARA amended the Controlled Substances Act (“CSA”) to enable physicians or patients to request pharmacists to partially fill prescriptions for schedule II substances including opioids and to allow remaining quantities to be filled up to 30 days after issuance of the prescription (up to 72 hours for emergency oral prescriptions). 21 U.S.C. §

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FDA Law Blog

DECEMBER 12, 2022

This blog post describes the medical device determination process and a way of assessing software functions to determine if your software product is subject to FDA regulations. Step 4: Is the software function intended to serve as electronic patient records? Likely FDA intends to exercise enforcement discretion.

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Physician's Practice

JUNE 25, 2025

Reynolds Blog Video Neil Baum, MD, asks whether your patients are satisfied with their care and shows how a quick survey could make the difference. If your patients are unhappy with care then they probably won't come back to your practice. June 25, 2025 By Neil Baum, MD Fact checked by Keith A.

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Patients Private Practice Management Healthcare 52

The Clinical Problem Solvers

SEPTEMBER 28, 2019

This is a peer-nominated group of academic clinicians renowned for their medical knowledge, teaching & communication skills, professionalism, and high-quality patient care. Some specific activities mentioned by the participants included patient-directed reading (e.g., NEJM , JHM , JGIM ).

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Noreta Family Medicine

JUNE 25, 2024

For instance, in May, I prescribed a diabetic medicine for a patient. The patient was unable to pick up the medicine due to the cost (about $1800), so I prescribed the other diabetic medicine in the same class. The cost was also above $1000 so the patient left the pharmacy empty handed. My patients have a say in their care.

Healthcare 52

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FDA Law Blog

SEPTEMBER 11, 2023

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

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FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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FDA Law Blog

DECEMBER 4, 2023

Lack of Individual Drug Therapy Pattern prescribing can occur when physicians prescribe the same drugs, in the same quantities, in the same strengths to their patients, or a patient receives the same controlled substances repeatedly with no adjustment or change in therapy. Complaint ¶ 58. Complaint ¶ 63.

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FDA Law Blog

JUNE 21, 2023

According to the announcement, enabling patients to access medical devices beyond traditional clinical settings can help close the healthcare gap by delivering care “directly to patients, wherever they are – at home, at work, in cities, in rural communities.” and remote or wearable patient monitoring devices (e.g.,

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FDA Law Blog

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. After a lab submits an MDR, FDA said that laboratories should save the electronic “Acknowledgement 3” (Ack3) generated after submitting an MDR in the MDR event files. It should be noted that 21 CFR 803.18(b)(1)(ii)

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FDA Law Blog

MAY 13, 2024

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. Patients that use ESD undergo continuous 24/7 monitoring. Patients are continually monitored for safety.

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FDA Law Blog

FEBRUARY 27, 2025

E6(R3) specifically acknowledges the rise of innovative trial designs such as adaptive and decentralized methods, while also encouraging the use of electronic informed consent and remote monitoring. As stakeholders begin implementing R3, many questions remain regarding its practical application.

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FDA Law Blog

MARCH 7, 2024

The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. Both documents also note that FDA may request copies of the DMC meeting records when the study is completed, and access to the electronic data sets used for each set of interim analysis.

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FDA Law Blog

AUGUST 27, 2023

The compliance policies described in the Guidance focus on the requirement that, beginning November 27, 2023, all trading partners generally will be required to use electronic-based approaches to meet the enhanced drug distribution security requirements set forth in in FDCA section 582(g)(1) (Enhanced Drug Distribution Security).

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Supply Chain Electronics Manufacturing Provider 52

PEMBlog

AUGUST 30, 2023

This is a blog post and a podcast episode designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

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Asthma Electronics Utilities Clinical Practice 52

Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. Neil Baum, MD Successful practices do not follow others; rather, they make their own paths and follow their own pathways and agendas.

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Management Patient-Centered Appointment Patients 52

Physician's Practice

JUNE 19, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article These essential strategies will enable your practice to safeguard digital assets and ensure compliance. Smartphones sit on the reception counter, physicians tap tablets at the bedside, and billing staff troubleshoot laptops from home.

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Management Patients Screening Finance 52

The Motivated MD

OCTOBER 10, 2024

With increasing emphasis on patient turnover and documentation, all while navigating the complexities of billing and authorization, our jobs are stressful and time-consuming. The Three Fund Portfolio This is where we ultimately return to an investment strategy I have written about previously on this blog.

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FDA Law Blog

MAY 4, 2023

This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). mobile applications to capture patient-reported outcomes through questionnaires). DHTs include monitoring instruments (e.g.,

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FDA Law Blog

OCTOBER 24, 2022

These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial. This value is potentially even greater for rare diseases, where there are limited sources of data.

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Electronics IT Healthcare Patients 78

FDA Law Blog

JULY 7, 2021

In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to treat patients with severe self-injurious and aggressive behaviors (SIB/AB), but did not restrict the use of these same devices for other purposes, like smoking cessation. Circuit Court of Appeals to overturn the ban.

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Medical Patient-Centered Patients IT 52

FDA Law Blog

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Combination products might be part drug, part device, or part software or hardware. FDA has shown a willingness to intervene in this space.

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FDA Law Blog

FEBRUARY 15, 2023

FDA is making these updates in part due to recognition that some of the records and reporting requirements are unnecessary to comply with the Electronic Product Radiation Control (EPRC) program (sections 532, 534(a)(1), and 537(b) of the FD&C Act (21 U.S.C. Thus, these regulations apply to a huge variety of products.

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FDA Law Blog

FEBRUARY 28, 2023

FDA announced on October 3, 2022 that the voluntary electronic Submission Template And Resource (eSTAR) templates would be required beginning October 1, 2023, as we blogged about here. Several sections of the eSTAR templates have questions that walk through related guidance documents.

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FDA Law Blog

DECEMBER 6, 2024

This summary covers everything from format and contents of INDs to their submission and use of the Electronic Submissions Gateway to cross-referencing other applications to FDAs review of the IND and the associated timelines. Section #1: FDA Interactions Given the wide range of sponsors (i.e.,

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FDA Law Blog

AUGUST 29, 2021

electronic formatting for regulatory submissions), scientific (e.g., clinical testing of implanted brain computer interface devices for patients with paralysis or amputation), enforcement (e.g., FDA’s database contains 2,623 guidance documents that address a plethora of topics, ranging from the mundane (e.g.,

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Government Electronics IT Clinic 52

FDA Law Blog

MARCH 20, 2022

In recognition that hard copy communications are slower and more cumbersome, FDA recommends that firms use electronic communications, as they lay out the details of the electronic means here , to notify the public about recalls. The saying “Hope for the best, prepare for the worst” applies to recalls.

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FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Data from chemical characterization studies must be evaluated in a separate TRA following ISO 10993-17 guidelines.

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GeriPal

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Alex: Okay.

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GeriPal

DECEMBER 8, 2022

Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. Storytelling Helps Hospital Staff Discover The Person Within The Patient. Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol.

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FDA Law Blog

JULY 7, 2024

FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] MDRs must be reported to FDA in electronic format.

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GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Eric: So patient narrative storytelling, independent of what we call it, I’d like to turn to both of you and just how you got interested in this as a subject. She was a heart failure patient.

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FDA Law Blog

JANUARY 8, 2023

Doctor-Patient Relationship. Also of great importance is the Act’s authorizing state-licensed physicians to advise patients or their legal guardians of the potential harms and benefits of cannabis derivatives as a medical treatment. 21 U.S.C. § Adequate and Uninterrupted Supply of Cannabis.

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