Regulatory Issues

Strategies and Considerations for Improving Global Healthcare

Strategies and Considerations for Improving Global Healthcare

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Although recent times have brought about significant technological and social advancements, the quality of healthcare worldwide continues to be inadequate.

FDA: Medtronic Update Addresses Cybersecurity Issue With CIED Programmers

FDA: Medtronic Update Addresses Cybersecurity Issue With CIED Programmers

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The vulnerability is associated with using an internet connection to update software between the Medtronic CareLink and CareLink Encore Programmers (models 2090 and 29901) and the Medtronic Software Distribution Network (SDN).

The Open Access Debate: Should Patients Freely Access Research?

The Open Access Debate: Should Patients Freely Access Research?

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Patients and their families are advocating for their right to access the latest medical research papers to help find potential treatments and understand health conditions.

Clinicians Raise Concerns About "Precision" Public Health in the Era of Genomics

Clinicians Raise Concerns About "Precision" Public Health in the Era of Genomics

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Although the trend of "precision public health" promises to change the landscape of the public health field, concerns surrounding the scientific, practical, and ethical implications have cast a shadow over the innovation.

AMA Opposition to the CVS-Aetna Vertical Merger Grows With Statement to DOJ

AMA Opposition to the CVS-Aetna Vertical Merger Grows With Statement to DOJ

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The American Medical Association has released a statement urging the US Department of Justice to block the CVS-Aetna merger.

Addressing Ethical Challenges Associated With Precision Medicine

Addressing Ethical Challenges Associated With Precision Medicine

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There is a continual debate regarding which approaches should be used to base stratification of patients to precision therapy.

Bioethics Concerns Should Be a Key Element in mHealth Technology Development

Bioethics Concerns Should Be a Key Element in mHealth Technology Development

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With the ubiquitous availability of digital technology such as smartphones, smart watches, health-related apps, and patient monitoring devices, the era of mHealth is upon us.

Addressing the Uncertainties of the Public Service Loan Forgiveness Program for Medical School Graduates

Addressing the Uncertainties of the Public Service Loan Forgiveness Program for Medical School Graduates

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The Public Service Loan Forgiveness (PSLF) program promises to forgive any remaining federal loan debt for employees at governmental or nonprofit institutions following 10 years of loan repayments.

Ethical Concerns Arise in Clinical Trial Enrollment as Number of Uninsured and Underinsured Americans Skyrockets

Ethical Concerns Arise in Clinical Trial Enrollment as Number of Uninsured and Underinsured Americans Skyrockets

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Until universal access to healthcare is ensured as a human right, researchers must keep important ethical concerns in mind when designing future clinical trials.

Medical Schools Phase Out Lectures as Education Shifts Outside the Classroom

Medical Schools Phase Out Lectures as Education Shifts Outside the Classroom

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Medical students are choosing to forego lectures to use the time studying for the Step 1 exam instead.

Challenges Associated With Proposed Changes to CMS Fee Structure

Challenges Associated With Proposed Changes to CMS Fee Structure

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A proposed restructuring of Centers for Medicare and Medicaid Services (CMS) Medicare Physician Fees may lead to an increase in required documentation and associated workload.

AHA, ADA, and Others Express Concern Around Proposed Legislation to Protect Those With Preexisting Conditions

AHA, ADA, and Others Express Concern Around Proposed Legislation to Protect Those With Preexisting Conditions

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The American Heart Association has published a statement in opposition of the latest Senate healthcare bill aimed at dismantling the Affordable Care Act.

Cochrane Data Release and the Case for Open Science

Cochrane Data Release and the Case for Open Science

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Cochrane's current policies allow only specific individuals with full library access to view and reuse data reports in their entirety.

Study Finds Clinical Trials for Newer, Breakthrough Therapies Lacking

Study Finds Clinical Trials for Newer, Breakthrough Therapies Lacking

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More than half of the new approvals of Breakthrough Therapy drugs were based on a single pivotal trial.

AMA <i>Code of Medical Ethics</i>: Guidelines for End-of-Life Care

AMA Code of Medical Ethics: Guidelines for End-of-Life Care

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Compassion and communication for both patients and families are among the most important factors involved in providing end-of-life care.

AMA Adopts Policy Promoting Health Equity As a Goal

AMA Adopts Policy Promoting Health Equity As a Goal

The American Medical Association House of Delegates has adopted a policy that sets health equity as a goal for the U.S. health care system.

FDA Seeks to Standardize Regulation of Mobile Medical Apps

FDA Seeks to Standardize Regulation of Mobile Medical Apps

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Appropriate and standardized regulation of mobile medical applications may enable faster adoption and integration of these technology platforms in the health care environment

ACA Coverage Gains Include Workers Without Insurance

ACA Coverage Gains Include Workers Without Insurance

After ACA was implemented, self-employed individuals and wage earners without employer-sponsored health coverage offers had coverage gains equal to or greater than those of people not employed.

Should Brand-Name Drug Manufacturers Be Held Liable for Generic Drug Counterparts?

Should Brand-Name Drug Manufacturers Be Held Liable for Generic Drug Counterparts?

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Both generic and brand manufacturers are protected from legal liability from failure-to-warn claims in most jurisdictions.

AMA Adopts Policy to Advance Gender Equity in Medicine

AMA Adopts Policy to Advance Gender Equity in Medicine

The American Medical Association (AMA) House of Delegates has adopted a new policy to study, act for, and advocate to advance gender equity in medicine.

Steps Taken to Increase Use of Electronic Tools in Medicine

Steps Taken to Increase Use of Electronic Tools in Medicine

Additional codes have been approved by the Current Procedural Terminology Editorial Panel for chronic care remote physiologic monitoring and internet consultations.

Republican Opposition to Obamacare: What's Done, What's to Come

Republican Opposition to Obamacare: What's Done, What's to Come

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Republicans who have fought against the Affordable Care Act (ACA) for years are at a crossroads after their opposition largely failed.

FDA Approval of Medication With a Digital Monitoring System: Major Breakthrough or "Brave New World"?

FDA Approval of Medication With a Digital Monitoring System: Major Breakthrough or "Brave New World"?

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Abilify MyCite adds a digital sensor to the medication aripiprazole. The sensor, an ingestible event marker, is activated by contact with stomach acids and transmits a signal to a skin patch the patient wears, which then transmits to an app.

AMA Proposes Policy Opposing Medicaid 'Lockout' Provisions

AMA Proposes Policy Opposing Medicaid 'Lockout' Provisions

A new policy opposing lockout provisions that block Medicaid patients from the program for lengthy periods and instead supporting allowing patients to reapply immediately for redetermination was adopted by the American Medical Association House of Delegates during the AMA's annual meeting in Chicago, according to an article published in the association's AMA Wire.

Marijuana's Uncertain Status: Closing the Gap Between State and Federal Policies

Marijuana's Uncertain Status: Closing the Gap Between State and Federal Policies

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Senator Elizabeth Warren introduced a bipartisan bill in June 2018 (S.3032) that would exempt most marijuana-related activities from the Controlled Substances Act when they are allowed under state or tribal law.

FDA Taps Social Media to Identify and Assess Emerging Drug Abuse Threats

FDA Taps Social Media to Identify and Assess Emerging Drug Abuse Threats

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The FDA continues to battle the nation's opioid problem even as it looks to detect and prevent the next threat.

New Short-Term Health Plans Have Large Coverage Gaps

New Short-Term Health Plans Have Large Coverage Gaps

There are large coverage gaps in short-term health plans that were approved Wednesday by the Trump administration.

The Halford Case Controversy: Are Institutional Review Board Regulations Too Strict?

The Halford Case Controversy: Are Institutional Review Board Regulations Too Strict?

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William Halford, PhD, reportedly administered a live attenuated herpes simplex virus vaccine to 17 participants at an off-campus hotel without approval from an institutional review board.

Medical Cannabis Legalization Associated With Reduced Schedule III Opioid Prescriptions

Medical Cannabis Legalization Associated With Reduced Schedule III Opioid Prescriptions

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In the United States, legalization of medical cannabis on a statewide basis was associated with a nearly 30% decrease in schedule III (but not schedule II) opioid prescription numbers and dosages for Medicaid patients.

Groups Urge CMS to Reconsider Suspending Risk Adjustment

Groups Urge CMS to Reconsider Suspending Risk Adjustment

Twenty-eight medical organizations, including AMA, sent letter to Administrator Verma of CMS

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