Posts Tagged “FDA”
ShowHide 3rd Party PapersShowHide Commentary
2011 Potpourri XXXXII
by Kevin Roche on Friday, October 28, 2011
Another brilliant Potpourri, with scintillating health care gems, including revising the FDA’s 510(k) process, the essential benefits package for health exchanges, the future of Medicare Advantage, the lack of labor productivity in health care, variation in elective procedure rates and the OIG’s work plan.
Tags: Care Management, Devices, FDA, Government, Health Care Costs, Health Care Reform, Health Insurance, Medical Care, Medicare, Physicians
2011 Potpourri XXXXI
by Kevin Roche on Friday, October 21, 2011
Another Potpourri, with tidbits on the Medicare Star program results for 2012, pain management, blood pressure management, Massachusetts’ physicians’ views on work and health care, online error reporting and the FDA and CMS parallel medical device review process.
Tags: Care Management, Devices, FDA, Health Insurance, Malpractice, Medical Care, Medicare, Physicians, Telemedicine
Off-Label Use of Atypical AntiPsychotics
by Kevin Roche on Tuesday, October 18, 2011
A Journal of the American Medical Association article, based on work sponsored by AHRQ, reviews the off-label use of atypical antipsychotics, which are usually very expensive and have significant side effects. While there are occasional benefits to such use, adverse events are common, particularly in the elderly.
Tags: Drugs, Elder Care, FDA, Health Care Quality
2011 Potpourri XXXIX
by Kevin Roche on Friday, October 7, 2011
October already!! Our 39th Potpourri of the year has many autumnal pleasures including selections on CMS’ Comprehensive Primary Care Initiative, a proposed guidance for FDA to use for mHealth regulation, end-of-life care discussions, CMS’ multi-payer database award, expected 2012 medical trend, and delivery of unnecessary care by doctors.
Tags: Care Management, Comparative Effectiveness, End-of-Life Care, FDA, Health Insurance, HIT, medical home, Medicare, Physicians, Telemedicine
FDA Strategic Plan
by Kevin Roche on Tuesday, September 6, 2011
The Food & Drug Administration releases its strategic plan for regulatory science, identifying priority areas and implementation strategies for each. How the FDA carries out its strategy over the next few years will greatly affect both the medical products industry and overall health spending.
Tags: Devices, Drugs, FDA, Regulation
2011 Potpourri XXIX
by Kevin Roche on Friday, July 29, 2011
Our current Potpourri contains nuggets on use of robotic surgery for prostate cancer, the effect of mandated rebates in Medicare Part D on patient costs, FDA guidance on device modifications, state Medicaid EHR incentive programs, patient understanding of trial data, and use of FQHC’s by Medicaid enrollees.
Tags: Devices, Drugs, EHRs, FDA, HIT, HITECH, Medicaid, Medical Care, Medicare
Regulation of Mobile and Wireless Health Technology
by Kevin Roche on Thursday, July 21, 2011
The FDA released a draft guidance on how it will regulate mobile and wireless healthcare devices and applications, which to a large extent follows proposed guidance from the mHealth Regulatory Coalition. The guidance may facilitate growth of this industry segment.
Tags: FDA, Mobile, Regulation, Wireless
2011 Potpourri XXVI
by Kevin Roche on Friday, July 8, 2011
Our current Potpourri features Google’s dropping of its PHR, the AMA’s report on insurer claims paying, the role of health advocacy groups, employer’s intentions in regard to offering health coverage, drug approval in the US versus Europe and the use of a checklist to improve quality in the ICU.
Tags: Drugs, FDA, Health Care Costs, Health Care Quality, Health Insurance, HIT, Physicians
Pharmacogenomics and the FDA
by Kevin Roche on Thursday, March 31, 2011
The FDA issues a draft guidance on the use of clinical pharmacogenomics, in particular the gathering of relevant pharmacogenomic data in early drug development studies.
Tags: Drugs, FDA, Personalized Medicine
2011 Potpourri XI
by Kevin Roche on Friday, March 11, 2011
Another in our weekly series of health care nuggets, with this week’s Potpourri featuring Medicare beneficiaries and physician supply, the FDA’s position on certain device software, a wellness survey, the AMA’s stance on genetic testing, marketing of drugs, and an integrated disability and health care program.
Tags: Consumers, Drugs, FDA, Genomics, Health Care Quality, Medicare, Mobile, Physicians, Wellness and Prevention
FDA’s 510(k) Recommendations
by Kevin Roche on Monday, February 7, 2011
The FDA’s 510(k) medical device approval process has been criticized for requiring too little data on potentially harmful devices. The FDA undertook a review of the process and has issued a description of initial steps it plans to take, which the industry seems to view as acceptable.
Tags: Devices, FDA, Regulation
FDA Regulation of Wireless and Mobile Health
by Kevin Roche on Wednesday, January 12, 2011
An incredibly useful paper has been issued by the mHealth Regulatory Coalition on issues surrounding potential FDA regulation of communications technology used for health-related purposes. The paper provides background and a discussion of the significant issues upon which the industry, patients and providers need guidance.
New Year Potpourri or 20ll Potpourri I
by Kevin Roche on Friday, December 31, 2010
Happy New Year and a prosperous 2011 to all of you, a prosperity which undoubtedly will be aided by the insights from our Potpourris, which this week include physicians’ use of patient satisfaction data, drugs for children, Medicaid quality measures, health reform provisions taking effect in 2011 and the FDA’s rate of drug approval in 2010.
Tags: Drugs, FDA, Health Care Quality, Health Care Reform, HIT, Medicaid, Medicare, Physicians
2010 Potpourri XXXIV
by Kevin Roche on Saturday, September 18, 2010
On the menu for this week’s potpourri–savings from wellness efforts for a large employer; drug reimbursement for Medicaid programs; using remote monitoring in a health plan context; the FDA’s regulatory approach to mobile health uses; the effect of tort reform on imaging rates and hepatitis C pay-for-performance measures.
Tags: Disease Management, Drugs, FDA, Health Care Reform, Malpractice, Mobile, Monitoring, Pay For Performance, Wellness and Prevention, Wireless
FDA’s Review of the 510(k) Process
by Kevin Roche on Tuesday, August 17, 2010
The Food and Drug Administration has been reviewing its 510(k) process, which is used for many medical device approvals. Two preliminary reports contain a series of recommendations designed to provide greater predictability in the process, while ensuring identification of significant safety concerns.
Tags: Devices, FDA, Regulation
GAO Report on Genetic Testing
by Kevin Roche on Thursday, August 12, 2010
Personalized medicine relies on genetic testing for much of its information. Direct-to-consumer genetic testing firms are widespread and a GAO report reveals that much of their work appears shoddy and their marketing deceptive. More regulation appears needed and on the way.
Tags: FDA, Personalized Medicine, Regulation
The FDA and Mobile Health
by Kevin Roche on Friday, June 25, 2010
An FDA lawyer posts an excellent summary of potential issues in regard to FDA’s regulation of mobile health devices and services. He suggests that industry adopt a proactive approach of proposing sensible regulations and guidance to FDA.
Tags: FDA, Mobile, Regulation, Telemedicine
2010 Potpourri XXII
by Kevin Roche on Saturday, June 19, 2010
Another weekend bonanza of health care items, including health insurance premium increases, genetic testing, remote patient monitoring, eye drug coverage by Medicare, emergency room use under the reform law and paying people to take their medicine.
Tags: Drugs, FDA, Health Insurance, Medical Care, Personalized Medicine, Telemedicine
ShowHide Headlines