Category:

According to PDS (PDS Life Sciences), SEND Express is a "turnkey solution for the generation of Standard for Exchange of Nonclinical Data datasets."...We aggregate and harmonize data from multiple organizations, information systems and file formats...to produce one set of harmonized SEND files, including define.xml and define.pdf, as required by the FDA...The platform's launch parallels the FDA's deadline for standardized electronic data submissions, which will require all datasets from studies supporting new drug applications, biologics license applications, and abbreviated new drug applications to be submitted in SEND format by Dec. 17...Having an industrywide, harmonized model allows for efficient analysis by regulatory authorities...The common formats assist in enabling the exchange of nonclinical data within companies and consortiums...this consistency of data makes it easier for vendors to develop tools that can use this data...

Starting on March 27, the way prescriptions are written in New York State will change. Gone will be doctors’ prescription pads and famously bad handwriting. In their place: pointing and clicking, as prescriptions are created electronically and zapped straight to pharmacies in all but the most exceptional circumstances...New York is the first state to require that all prescriptions be created electronically and to back up that mandate with penalties, including fines and imprisonment, for physicians who fail to comply. Minnesota has a law requiring electronic prescribing but does not penalize doctors who cling to pen and paper...Just as doctors putting away their pads will face a culture change in New York, so, too, will patients, who will no longer be able to shop around for the shortest waiting time or the best price for their medications...“It’s probably driven us to prescribe more standardized regimens and more standardized dosing,” said Dr. Paul A. Testa, the chief medical information officer at NYU Langone. “And the reality is, there is always the phone. If I have a doubt, I can call the pharmacy.”

Dartmouth College researchers claim to have developed a "magic wand" they say will prevent hackers from stealing personal data. They've named the digital tool Wanda...The focus of the work is to secure data at home on patients' computers, laptops, tablets, mobile phones and medical devices...Wireless and mobile health technologies have great potential to improve quality and access to care, reduce costs and improve health...But these new technologies, whether in the form of software for smartphones or specialized devices to be worn, carried or applied as needed, also pose risks if they're not designed or configured with security and privacy in mind...one of the main challenges is that most people don't know how to set up and maintain a secure network in their home. That...can lead to compromised or stolen data or potentially allow hackers access to devices such as heart rate monitors or dialysis machines. That's where Wanda comes in...A small device that has two antennas separated by one-half wavelength and uses radio strength as a communication channel...The digital tool makes it easy for people to add a new device to their home – or clinic – Wi-Fi network...Users need only pull the wand from a USB port on the Wi-Fi access point, carry it close to the new device and point it at the device, like a magic wand. The wand securely beams the Wi-Fi network information to the device while preventing anyone nearby from capturing or tampering with the information...

David D'Altorio, PharmD, senior vice president of health services at MedImpact Healthcare Systems, discusses the benefits of MedImpact's iRx program.

LexisNexis Risk Solutions, a leading provider of data, analytics and technology, on Monday announced the rebranding of Health Market Science, its most recent acquisition, as LexisNexis Risk Solutions in the Pharmacy market. The rebranding initiative reflects the organization’s commitment to combine its industry-leading public records footprint and prescriber data, leveraging analytics and big data technology in the pharmacy space...Over the last four years...we have...achieved – a very specific course for growth within the health care data analytics market, and the pharmacy space has been a top priority since day one...We are pleased to have partnered with all of the major retail pharmacy chains and the majority of the Pharmacy Benefit Managers...In a market with an increasingly stringent and complex regulatory environment, pharmacies without the ability to perform real-time compliance checks put themselves at risk. By combining the referential database with the company’s public records footprint, analytics and big data technology, LexisNexis Risk Solutions can offer a continuum of prescriber data assets, analytics and services that allow pharmacy customers to remain compliant.

Health apps, like prescription drugs, come with side effects, it turns out...an astoundingly large number of health apps may be sharing users’ medical information. Many can also switch on smartphone cameras and make changes to the software on your phone...More than 80 percent of the 211 diabetes apps studied did not have privacy policies. And out of a randomly selected subset of 65 apps, 56 of them used tracking cookies, which could allow them to send information about the user to other companies, such as marketing firms...sharing or selling of personal information could lead to discrimination. Users with certain medical profiles...could have a tougher time getting life insurance...The apps are not bound by HIPAA...They are free to trade, sell, and use the information in any way that they want...There’s a lot more than blood glucose tracking on these apps...the fine-print permissions that all users have to accept before downloading a diabetes app, they found that 17 percent asked to track the user’s location, 11 percent sought to switch on the smartphone camera, and 64 percent requested the ability to delete or modify information anywhere on the user’s phone...Most health apps are completely unregulated. If you don’t want your information shared or the memory on your phone tampered with, be very careful about which apps you choose to download.

...online market giant Alibaba Group launched a pilot medical service last month in China that promises a patient can visit a doctor online and get his prescription filled the same way with home delivery and payment to boot...part of Alibaba's health business, aims to tap into a market that iResearch said had an estimated revenue stream of 16 billion yuan ($2.4 billion) last year…We want to build a health care product sales platform that links manufacturers, wholesalers and retailers to offer various medical products and services to customers…The pilot saw patient Hu Tianshun enter medical data via an online form and then a video chat with a doctor in another city was held…adding the doctor made a diagnosis and places a online prescription order with an Alibaba's online shops...Hu got his drugs the next day, and completed the transaction by paying the deliveryman…

CMS said it plans to add about 1,900 diagnosis codes and 3,651 hospital inpatient procedure codes to the coding system…On Oct. 1, the Centers for Medicare and Medicaid Services will add another 5,500 codes to the ICD-10 diagnostic library, officials announced…The addition will come exactly one year after ICD-10, with its nearly 70,000 billable codes, replaced the dated, and much more compact, ICD-9 code set… The new and revised ICD-10-CM (Clinical Modification) and ICD-10 PCS (Procedure Coding System) codes will be included in the hospital inpatient prospective payment system proposed rule for fiscal 2017…

Nevada's Office of Vital Statistics issued a call this month for relevant physicians to sign up as quickly as possible for a system that allows doctors to fill in required information for death certificates electronically. That system became mandatory statewide Jan. 1...Some doctors did not sign up after the state began notifying them of the change in fall because they have had issues registering or have outright refused to participate, vital records program officer Jason Lewis said...Karen Massey, chief administrative officer at Northern Nevada Emergency Physicians, said physicians have struggled with some requirements of the system, including its incompatibility with Windows 10 and Apple computers. The changeover has been time-consuming...I'm dismayed when it sounds like physicians haven't been responsive about it...Physicians have raised several concerns and have been working with the state to get them resolved...

...the Institute for Critical Infrastructure Technology, a bipartisan collaborative meant to bridge the gap between federal agencies and private-sector leaders in the interest of protecting the nation's technology backbone, claims recent guidance from Food and Drug Administration for device makers falls way short...In practically all matters of cybersecurity within the health sector, the FDA seems to be in a constant state of offering subtle suggestions where regulatory enforcement is needed..."Assessing the FDA's Cybersecurity Guidelines for Medical Device Manufacturers: Why Subtle 'Suggestions' May Not Be Enough," knocks the agency for failing to implement enforceable regulations for manufacturers...It may be beneficial to healthcare providers, healthcare payers, and legislators to petition the FDA to make the guidelines regulatory. Otherwise, medical device manufacturers could ignore the guidelines altogether...