FDA

See the following -

A New Meaning for Connected Health at 2016 Symposium (Part 2 of 4)

Andy Oram | EMR & HIPPA | November 4, 2016

Tullman’s principles of simplicity, cited in the previous section, can be applied to a wide range of health IT. For instance, AdhereTech pill bottles can notify the patient with a phone call or text message if she misses a dose. Another example of a technology that is easily integrated into everyday life is a thermometer built into a vaginal ring that a woman can insert and use without special activation. This device was mentioned by Costantini during her keynote. The device can alert a woman–and, if she wants, her partner–to when she is most fertile. Super-compact devices and fancy interfaces are not always necessary for a useful intervention. 

Read More »

Big Health Advances in Small Packages: report from the third annual Medical Device Connectivity conference

Andy Oram | O'Reilly Radar | September 9, 2011

At some point, all of us are likely to owe our lives--or our quality of life--to a medical device. Yesterday I had the chance to attend the third annual Medical Device Connectivity conference, where manufacturers, doctors, and administrators discussed how to get all these monitors, pumps, and imaging machines to work together for better patient care. Read More »

Cloudera Chief Scientist Jeff Hammerbacher Teams With Mount Sinai School of Medicine to Solve Medical Challenges Using Big Data

Press Release | Cloudera, The Mount Sinai Medical Center | July 3, 2012

Cloudera...today announced that Cloudera Cofounder and Chief Scientist Jeff Hammerbacher will be leading a revolutionary project with Mount Sinai School of Medicine to apply the power of Cloudera's Big Data platform to critical problems in predicting and understanding the process and treatment of disease. Read More »

Department of Health APIs to Expand Web Content

Andy Oram | EMR & EHR | October 21, 2015

Application Programming Interfaces (APIs) appeal mostly to statisticians and researchers whose careers depend on access to data. But these programming tools are also a useful part of a Web that is becoming increasingly supple and sophisticated. I have written a series of articles about the use of APIs to share and run analytics on patient data, but today I’ll cover a cool use of an API developed by the Department of Health and Human Services for disseminating educational material. The locus for this activity started with the wealth of information created by the Centers for Disease Control for doctors, public health workers, and the general public. Striving to help the public understand vaccinations, West Nile fever, Ebola (when that was a major publicissue), and even everyday conditions such as diabetes, the CDC realized they had to make their content simple to embed in web sites for allthose audiences.

Read More »

Drug Giant Glaxo Pleads Guilty, Fined $3B for Drug Marketing

Staff Writer | USA Today | July 2, 2012

Drug giant GlaxoSmithKline will plead guilty and pay $3 billion to resolve federal criminal and civil inquiries arising from the company's illegal promotion of some of its products, its failure to report safety data and alleged false price reporting, the Justice Department announced Monday. Read More »

Economist, Why so Pessimistic about Open Source Medical Devices Software?

medicaldeviceslegal | Erik Vollebregt | June 11, 2012

I read an interesting article in the Economist’s Technology Quarterly of June 2nd-8th of 2012, p. 17-18, on open source medical devices software. Let me summarise for you: the article starts by showing all the benefits of medical devices software that is developed using open source models, and there are many...The article concludes however that open source has no place in the current regulatory environment and points only to FDA regulation for that conclusion. Read More »

EU Agency Lifts Lid on Drug Data Secrets

Ben Hirschler | Reuters | July 15, 2012

Europe's medicines regulator, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information. Read More »

FCC to Look into Possible Problems Using Wireless Medical Devices

Deborah Hirsch | HealthTechZone | June 6, 2012

Studies show that mobile medical devices, such as the ability to recieve dialysis at home for kidney disease patients, could save as much as $197 billion over the next 25 years while improving patient care. Read More »

FDA Issues Proposed Rule for Unique Device Identifiers

Ken Terry | FierceHealthIT | July 5, 2012

Five years after a request from Congress, the Food and Drug Administration (FDA) has finally issued a proposed rule that would mandate the placement of unique device identifiers (UDI) on medical devices. Among other things, the use of UDIs will facilitate the reporting of adverse events related to these devices so that the FDA can more quickly address them and recall devices if necessary. Read More »

FDA Seeks Data Mining Tool to Track Adverse Drug Reactions

Joseph Marks | NextGov | July 24, 2012

The Food and Drug Administration is in the market for a data mining tool that will gather information on adverse reactions to vaccines and other drugs, according to solicitation documents posted Monday. Read More »

FDA: Software Failures Responsible for 24% Of All Medical Device Recalls

Paul Roberts | threatpost.com | June 20, 2012

Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the U.S. Food and Drug Administration, which said it is gearing up its labs to spend more time analyzing the quality and security of software-based medical instruments and equipment. Read More »

General Dynamics Closes $960M Vangent Acquisition

Nick Wakeman | Washington Technology | September 30, 2011

General Dynamics Corp. has closed its $960 million acquisition of Vangent Inc. in a move that builds out GD’s health care IT business. The company becomes part of General Dynamics IT and creates a health care business that stretches across both civilian and defense agencies. Read More »

Harvard Law Conference Surveys Troubles With Health Care

Andy Oram | EMR & EHR | March 30, 2016

It is salubrious to stretch oneself and regularly attend a conference in a related field. At the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, one can bask in the wisdom of experts who are truly interdisciplinary (as opposed to people like me, who is simply undisciplined). Their Tenth Anniversary Conference drew about 120 participants. The many topics–which included effects of the Supreme Court rulings on the Affordable Care Act and other cases, reasons that accountable care and other efforts haven’t lowered costs, stresses on the pharmaceutical industry, and directions in FDA regulation–contained several insights for health IT professionals...

Read More »

Hospitals Fight Drug Scarcity, Fear Patients Harmed

Anna Yukhananov | Open Source Portal.org | June 1, 2012

At the Henry Ford Hospital in Detroit, pharmacists are using old-fashioned paper spreadsheets to track their stock of drugs in short supply – a task that takes several hours each day...A few hundred medicines make the list of drugs in short supply: anesthetics, drugs for nausea and nutrition, infection treatments and diarrhea pills. A separate list has scarce cancer drugs for leukemia or breast cancer.
Read More »

How to Make Your Government Agency More Innovative

Tom Fox | Washington Post | June 5, 2012

The words innovation and government may not be synonymous, but “the times, they are a-changin.” Last month, the White House launched a Presidential Innovation Fellows program that will bring in 15 innovators from outside government to provide expertise on five technology projects. Read More »