Category Archives: Uncategorized

Upcoming AACC Conference in Atlanta

PeachTreeThis year’s major diagnostics conference, the AACC, will be in Atlanta from July 26-30.

Industry participants from around the world will gather at this event which seems to get bigger each year presumably reflecting the growing role of diagnostics in medical care.

If you plan to attend this year’s AACC, please let me know and we’ll find a time to meet.

SF Life Science Week Recap

IMG-20140112-00087Life science week in San Francisco this year, as every year, was a whirlwind of meetings, presentations and receptions.

Attendance this year, judged anecdotally by the crowds at events and the price and availability of hotel rooms, was larger than last year.

Weather in San Francisco was great, not too hot or too cold and no rain.

I was able to get meetings with most of the companies I had identified to meet for the first time or to simply catch up.

What was especially rewarding for me were the serendipitous (if that’s a word) meetings and presentations. I stumbled upon some great companies and people by accident by attending some presentations when I had a break in my schedule of meetings or by chatting with people I met in the hallways and on the street between events.

It makes sense that the event grows each year if other attendees find the same value in the week that I did.

I look forward to following up on my meetings this year and planning ahead for next year.

Cost of Cancer Drugs

TidalWaveOngoing pressure to reduce treatment costs in the face of the looming demographic wave of healthcare costs prompted this article on the cost of cancer drugs in the “New England Journal of Medicine”.

Excerpt

“The high cost of cancer drugs has been criticized by leading academics and lamented in the popular press.  The average price of 1 year of treatment with a new cancer drug now exceeds $100,000, and the benefits of many of these therapies — often improvement in median survival on the order of weeks to months — do not appear commensurate with their prices.

Expensive cancer drugs cost society in two ways. First, high prices are borne by payers each time these drugs are prescribed. And second, high prices preclude independent comparative effectiveness trials that would seek to establish equally effective but cheaper alternatives — thereby protecting the market share of expensive drugs.

Click here to read the article in the “New England Journal of Medicine”.

Mobile Apps Require FDA Review

SmartphoneAppsThe Food and Drug Adminstration, FDA, has provided final guidance to determine which mobile apps may require FDA scrutiny and regulation.

The more the mobile app’s intended used is as an integral part of the functioning of a medical device, the more likely it falls within regulatory scrutiny.  For example, a mobile app used to read the results of diagnostic tests are likely to be defined as a “mobile medical app” and, therefore, face FDA review.

At the other end of the spectrum, mobile apps that are used for normal office functions such as scheduling office visits or reminding patients about non-medical behavior such as getting sufficient exercise, are unlikely to face review.

Click on the links below or copy and paste the links into your browser to read a helpful summary of the FDA announcement by Foley & Lardner, the law firm, or the FDA guidance.

http://www.jdsupra.com/legalnews/fda-submits-final-guidance-on-mobile-med-92633/

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf
 
 By Dennis McCarthy
 Google

HIPAA Compliance Gap

CoalfireLogoMore stringent HIPAA compliance rules went into effect on September 23rd following their announcement last January.

While many in the healthcare industry are compliant, a survey by Coalfire, a risk assessment firm, indicates that many firms that serve the healthcare industry and now fall under the definition of “Business Associates” are not fully compliant.

This gap in compliance by business associates, while likely unintentional, opens their healthcare industry customers to liability.

Please click here or copy and paste the link below to go to the Coalfire survey summary.

http://www.coalfire.com/News-and-Events/Press-Releases/Coalfire-Survey-Reveals-Low-Compliance-as-Deadline
 
 By Dennis McCarthy
 Google