Global Patenting Strategy & Practice
June 17th, 2013
in Legal Conferences, Litigation, Regulatory & Compliance |
Your Marketplace is Global – Ensure that Your Patent Protection is Too.
When: Monday, July 15 to Tuesday, July 16, 2013
Where: The Carlton Hotel, New York, NY
To learn more & register: Click Here
Industry News
Industry Related Article by Inovia posted 05/06/2013
Inovia, the leading foreign filing provider, today announced the release of its annual report, “The 2013 U.S. Global Patent & IP Trends Indicator,” an in-depth look at how the economy has impacted global IP strategy and its influence on future foreign filing plans. inovia announced the annual survey findings at the 135th Annual Meeting of the International Trademark Association taking place May 4-8 in Dallas.
Similar to the findings in previous years, foreign patent filing is on an upswing with large organizations continuing to outsource much of the foreign patent filing process to non-law firm providers as a means to cut costs and gain efficiencies. More than half of those surveyed filed at least 50 percent of their patent applications overseas, reflecting the growing importance of international patent protection among U.S. companies.
Now in its fourth year, the Indicator has become a definitive resource for identifying the trends having the greatest impact on the foreign filing strategies of U.S. patentees. The mood for 2013 was again “Cautiously Optimistic,” with the number of patent families expected to be filed in 2013 in-line with 2012 filings.
The changes brought by U.S. patent reform and key provisions of the America Invents Act going into effect in March 2013 were overwhelmingly cited by respondents as the most important topic for the IP industry in 2012 and into 2013. Other trends anticipated in 2013 include concerns around the rising cost to obtain patent protection, as well as patent enforcement and patent trolls.
Other key findings from the Indicator include:
- International Patent Filing on the Rise: Compared to the 2012 survey results, respondents this year tended to file more broadly with 70 percent filing in four or more countries – an 11 percent increase from the year prior. As in previous surveys, the overwhelming majority (99 percent) of respondents used the Patent Cooperation Treaty (PCT) for their foreign filing in 2012.
- China Becomes Regular Filing Destination vs. Emerging Market: Of those respondents who filed into new countries, only 14 percent started filing into China in 2012, down from 28 percent in 2011. But, when asked to rank the importance of certain jurisdictions in their 10-year foreign filing strategy, Europe, China and Japan rated as the most important countries – indicating that China has become a regular filing destination. Respondents also expressed fewer concerns about enforceability issues in China.
- Applicants Taking Control of Foreign Patenting: As compared to 2012 results, more applicants expect to save on foreign patenting costs in 2013 by bringing steps in-house (91 percent increase from 2012 survey results), negotiating with foreign counsel (74 percent increase) and using non-law firm providers (73 percent increase).
“The theme of Cautious Optimism returns for the third-consecutive year, with budget cuts lessening and large companies moving away from local counsel for foreign patent filing,” said inovia founder and Australian patent attorney Justin Simpson. “As U.S. patent holders continue to struggle with the changes made by the America Invents Act and a desire to contain costs, they are opting to bring steps in-house or outsource to non-law firm providers with deep experience in areas such as foreign filing, annuities and patent translations.”
inovia surveyed companies and universities through an online questionnaire. Organizations spanned industries and ranged from small enterprises filing a single patent family to multinational organizations filing more than 100 patent families in 2012. All survey participants are involved in the IP strategy and patent filing activity of their organization, with job functions ranging from patent manager, to general counsel and up to executive leadership positions. To download a copy of inovia‘s 2013 U.S. Global Patent & IP Trends Indicator, visit: http://www.inovia.com/resources/global-ip-trends-indicator
- See more at: http://www.inovia.com/news/050313-annual-survey-shows-ip-outsourcing-become-commonplace.jsp#sthash.1wcWs9a8.dpuf
Legal and Regulatory Summit on Generic Drugs
June 12th, 2013
in Legal Conferences, Pharmaceuticals / Biotech / Life Sciences, Regulatory & Compliance |
Equip Yourself with the Tools and Know-How that You Need to Navigate the Generic Drug Industry’s Rapidly Evolving Legal, Regulatory and Political Landscape
When: Wednesday, July 17 to Thursday, July 18, 2013
Where: The Carlton on Madison, New York City, NY
For more information and to register: Click Here
Industry News
Industry Related Article by Foo Yun Chee, posted 06/03/2013
A European regulator will fine Denmark’s Lundbeck and eight other makers of generic drugs for limiting the supply of cheaper medicines, two people with knowledge of the matter said, its first sanction against “pay-for-delay” deals.
Following an inquiry launched in 2009, the European Union’s anti-trust regulator will impose a “significant” fine on Lundbeck and lesser fines on Germany’s Merck KGaA this month, the people said. Seven smaller drug firms will also be fined.
The sanctions underscore the determination of EU and U.S. regulators to break agreements that involve brand-name drug companies paying generic manufacturers not to deliver cheaper versions of their drugs to the market, a practice that ultimately harms consumers.
European regulators have estimated that consumers are paying up to 20 percent more for medicines in some cases. Generic versions typically cost a fraction of the price of original medicines in Western markets.
The pharmaceutical industry will be looking for guidance from the case as to what is lawful and what is not, said Koen Platteau, a partner at Brussels-based law firm Olswang.
“The Commission clearly wants to send out a message that in circumstances, this kind of agreement can be restrictive. This is the first case where they will set a precedent,” he said.
The European Commission, the EU’s antitrust regulator, can fine a company up to 10 percent of its global revenue for breaching competition laws. In the case of Lundbeck, which makes an anti-depressant drug and a treatment for Alzheimer’s, that would be up to 240 million euros ($311.04 million).
The people Reuters spoke to did not give the precise size of the fines.
“The fine for Lundbeck is expected to be significant, less so for the others,” said one of the people, who declined to be identified because of the sensitivity of the matter.
Lundbeck paid the generics firms to keep its products from the market and bought stocks of the generic anti-depressant drug citalopram to be destroyed, the person said.
A spokesman for Lundbeck said the company had not been notified of any fine and believed it had done nothing wrong. Lundbeck shares fell 1.9 percent after Reuters reported the fine. They were trading 1.4 percent lower at 109.2 crowns by 11:16 a.m. EDT.
The other companies to be fined are Generics UK, Arrow, Resolution Chemicals, XelliaPharmaceuticals, Alpharma, A.L. Industrier and India’s No. 1 pharmaceutical company Ranbaxy, all of them makers of generic drugs. Ranbaxy declined to comment.
A Merck KGaA spokeswoman said the company, which sold subsidiary Generics UK to U.S. generic drugmaker Mylan in 2007, does not comment on pending legal issues.
Antoine Colombani, the spokesman for competition policy at the Commission, declined to comment.
The EU competition authority has two similar cases in the pipeline, involving Israel’s Teva, French drugmaker Servier, Johnson & Johnson and Novartis.
The U.S. Federal Trade Commission has battled against such deals in court for more than a decade. The U.S. Supreme Court is expected to decide on the issue by the end of the month after lower courts issued conflicting rulings.
Brand name companies have defended “pay-for-delay” deals in large part to protect patents and avoid costly litigation.
In a typical case, a generic rival may challenge the patent of a brand-name competitor, which then pays the rival a sum of money to drop its challenge. Defenders of the practice call it a legitimate means to resolve patent litigation. ($1 = 0.7716 euros)
Anti-Corruption Compliance in High Risk Markets
June 11th, 2013
in Anti-Corruption / FCPA, Legal Conferences, Regulatory & Compliance, Surveys and Polls |
Anti-Corruption Investigations and Prosecutions are Increasing Globally. Can Your Anti-Corruption Compliance Program Sustain the Heat of a Government Investigation? Learn What it Takes to Ensure Your Operations in High Risk Markets are Compliant with Relevant Anti-Corruption Laws.
When: Monday July 22th, to Wednesday July 24th, 2013
Where: Washington Marriott Hotel, Washington, DC
For more information, and to register: Click Here
Industry Related Poll
Tags: ACI Event
No Comments »
Firing After Facebook Posts Deemed Unlawful and Leads to Additional Order to Rescind Unrelated Salary Non-Disclosure Policy
June 10th, 2013
in Employment & Benefits, Expert Guest Blog Entries, Regulatory & Compliance |
Expert Article by Emily C. Wilcheck, from alawemployment.blogspot.com posted on 05/29/2013
In Design Technology Group, LLC d/b/a Bettie Page Clothing, NLRB Case No. 20-CA-035511, the National Labor Relations Board (“NLRB” or “the Board”) concluded that the employer’s conduct of terminating non-union employees for postings on Facebook violated provisions within the National Labor Relations Act (“NLRA” or “the Act”) protecting concerted activity amongst coworkers to improve their working conditions.
The terminated employees in the Bettie Page case worked in a women’s retail store located in California. Amongst other complaints, they had expressed concerns with management about safety arising from the fact that their store remained open for an hour after other stores in the area had closed, and that there was no alarm or security system within the store. After an argument with her manager over this issue, one of the employees, Holli Thomas, posted to her Facebook page that she “needs a new job” and that she was “physically and mentally sickened.” Her post lead to the following exchange on Facebook between the coworkers:
- Vanessa Morris: It’s pretty obvious that my manager is as immature as a person can be and she proved that this evening even more so. I’m am [sic] unbelievably stressed out and I can’t believe NO ONE is doing anything about it! The way she treats us in [sic] NOT okay but no one cares because everytime we try to solve conflicts NOTHING GETS DONE!!!!
- Holli Thomas: bettie page would roll over in her grave.
- Vanessa Morris: She already is girl!
- Holli Thomas: 800 miles away yet she’s still continues [to make] our lives miserable. Phenomenal!
- Vanessa Morris: And no one’s doing anything about it! Big surprise!
- Brittany Johnson: “bettie page would roll over in her grave.” I’ve been thinking the same thing for quite some time.
- Vanessa Morris: hey dudes it’s totally cool, tomorrow I’m bringing a California Worker’s Rights book to work. My mom works for a law firm that specializes in labor law and BOY will you be surprised by all the crap that’s going on that’s in violation J see you tomorrow!
Ms. Morris did bring in the book about worker’s rights and placed it in the breakroom. Another sales employee told the manager about the above Facebook postings. The manager accessed that employee’s Facebook page and viewed the postings. The owner was also eventually notified of the postings. A few days later, the manager terminated Ms. Thomas and Ms. Morris because “things were not working out.”
Shortly after she terminated Ms. Thomas and Ms. Morris, the manager noticed that another employee who participated in the Facebook discussion, Brittany Johnson, had received a text message from Ms. Thomas. The manager told Ms. Johnson that she was tempted to put a “gag order” on her so that she would not be able to talk with others about her working conditions. Approximately one month later, the manager discharged Ms. Johnson purportedly for tardiness.
On review, the Board concluded that the postings among the three employees were protected concerted activity under the Act. Moreover, the Board found that the employer’s justifications for the terminations (insubordination, misuse of company computers, and tardiness) were mere pretext for unlawful retaliation against these employees for their protected activity. Moreover, in the course of investigating this unfair labor practice, the Board examined the employer’s handbook and found that the employer had also engaged in an unfair labor practice by maintaining a policy prohibiting employees from disclosing wages and compensation to each other or to any third party. Accordingly, the Board ordered the employer to not only reinstate these three employees with full back pay, but also required the employer to publically rescind their wage and salary non-Disclosure policy at all locations company-wide where this rule was in effect.
This decision reinforces the NLRB’s stance that the rights of both union and non-union employees to protest supervisory conduct that affects working conditions remain protected even when done through social media. Moreover, employers facing such unfair labor charges may find themselves defending employment policies that are unrelated to the underlying conduct — a good reason to review such policies and practices to make sure that they do not violate the Act.
Tags: Employment Law, National Labor Relations Act
No Comments »
White House Nominates New CPSC Commissioner and CPSC Adds Director of Compliance and Field Operations
June 5th, 2013
in Expert Guest Blog Entries, Legal Conferences, Regulatory & Compliance |
Expert Article by Christie Grymes Thompson
- Christie will be speaking at ACI’s Consumer Products Regulation & Litigation Conference on June 26th to 27th,2013.
With a looming departure date for Consumer Product Safety Commission (“CPSC” or “Commission”) Commissioner Nancy Nord that would leave the CPSC without a quorum, the Obama Administration announced last week the nomination of former Rep. Ann Marie Buerkle to serve as a Republican Commissioner. During her single term, Congresswoman Buerkle criticized what she described as an unchecked growth of government that stifled the free enterprise of small businesses. Her nomination will likely be paired with Marietta Robinson’s nomination, President Barack Obama’s pick in 2012 to fill the seat left vacant by Democratic Commissioner Thomas Moore.
In the wake of the White House’s nomination, Ray Aragon quietly became the Commission’s Director of Compliance and Field Operation. Although the CPSC has not issued a press release announcing the new Director or modified its online organization chart, Mr. Aragon is listed in the CPSC’s phone directory and presumably has begun handling matters. Mr. Aragon was most recently a partner at McKenna Long & Aldridge LLP, with a commercial litigation practice that included product liability claims.
This Kelley Drye advisory provides background regarding these two individuals and what the new leadership means for the CPSC.
Follow the link to learn more & register for ACI’s Consumer Products Regulation & Litigation Conference on June 26th to 27th,2013
ACI’s 6th China Summit on Anti-Corruption
June 4th, 2013
in Anti-Corruption / FCPA, China & Singapore |
Unparalleled networking and benchmarking opportunities at China’s premier anti-corruption compliance forum. An international faculty of senior-level executives who will provide you with information you can’t get anywhere else.
When: Tuesday, June 18 to Wednesday, June 19, 2013
Where: Shanghai InterContinental Pudong, Shanghai
For more information, and to register: Click Here
Industry News
Industry related article from FCPABlog.com, by Richard L. Cassin, posted on 05/03/13:
Mark King of Rolls Royce (Photo courtesy of Rolls Royce)The head of Rolls-Royce’s aerospace division resigned Monday amid reports the company is close to resolving civil charges with the Serious Fraud Office for bribery in China, Indonesia, and other countries.
Mark King resigned after being promoted to his job just four months ago, the Guardian reported Thursday.
He’ll leave at the end of June, the Guardian said.
King joined the aircraft engine maker in 1986 and previously headed the civil aerospace division, now at the center of the bribery allegations.
The company said he was leaving for personal reasons.
Late last year, reports appeared in China that Rolls-Royce bribed executives of Air China and China Eastern Airlines to win sales in 2005 and 2010.
The company said in December that the U.K. Serious Fraud Office had asked it to investigate allegations of misconduct involving intermediaries in Indonesia and China.
The Indonesia allegations arose after a whistleblower, former Roll Royce employee Dick Taylor, ‘claimed that Tommy Suharto – a son of the late President Suharto – received $20 million and a Rolls Royce car to persuade the national airline, Garuda, to order Rolls Royce Trent 700 engines in 1990,’ the Guardian reported last year.
The Guardian said Thursday that Rolls-Royce and the SFO are ‘reportedly close to reaching a civil settlement to halt the bribery inquiry. Any agreement may involve a multimillion-pound fine, but avoid criminal charges. Rolls-Royce and the SFO declined to comment.’
Rolls-Royce chief executive John Rishton told shareholders this week it has been ‘particularly disappointing to discover matters of concern. . . . This is a company with exceptional prospects and I will not accept any behaviour that undermines its future success.’
Tags: ACI Event, Anti-Corruption China, Compliance, FCPA
No Comments »
ACI’s 4th Biosimilars Conference
June 3rd, 2013
in Healthcare, Pharmaceuticals / Biotech / Life Sciences |
Attend the one event where the industry leaders driving the business of biosimilars unite to set the standards which will shape an evolving legal and regulatory landscape.
When: Thursday, June 06 to Friday, June 07, 2013
Where: New York Marriott Downtown, New York, NY
For more information, and to register: Click Here
What Previous Attendees said about this Annual Leading Event:
- “ One of the best CLEs I’ve been to in 10 years”
- “Excellent program – informative and thought-provoking.”
- “I thought all the speakers did an excellent job in terms of content and delivery.”
- “Excellent seminar. A lot of learning, new points of view talked about and dealt with.”
Industry News
Industry related article from FierceBiotech.com, by Ryan McBride, posted on 04/18/13:
Roche ($RHHBY) might face a reduced threat from one copycat competitor to its blockbuster Rituxan franchise. The South Korea-based biotech Celltrion has nixed late-stage development of a biosimilar version of Rituxan, which is expected to face knockoff rivals first in Europe and then in the U.S. in the coming years, Bloomberg reported.
As Bloomberg reported, Celltrion aimed to advance its biosimilar candidate CT-P10 into Phase III development this year, yet the European Medicines Agency’s clinical trials registry lists the planned study for patients with non-Hodgkin lymphoma as terminated. However, Celltrion and its partner Hospira might only be delayed in their pursuit of a Rituxan biosimilar, as Celltrion has issued a statement saying that it plans to push ahead with late-stage development later in 2013, RBC Capital Markets wrote to investors this morning.
“The biosimilar opportunity for Hospira has been a tenet of the bull thesis, as management has touted that Hospira has 11 biosimilar molecules under development that target $40 billion of branded value,” RBC analysts wrote this morning. “If the trial was terminated due to complications, it would validate our view that developing biosimilars is very difficult and complex, and may not lead to scientific, regulatory, or commercial success.”
Samsung Electronics and Teva Pharmaceutical ($TEVA) both bailed out on biosimilar versions of rituximab (MabThera/Rituxan) last year amid uncertainty in regulation of copycat biologics in the U.S. and expensive development requirements that reduce the financial rewards of the drugs. Yet the $7 billion seller could find competition from others, as both Novartis’s ($NVS) Sandoz unit and Boehringer Ingelheim have had Rituxan in their biosimilar plans.
It’s no wonder why biosimilars players are eyeing Rituxan: On top of huge sales, the antibody drug loses patent exclusivity in Europe later this year, Reuters reported, and exclusivity vanishes in 2018 in the U.S., where Biogen Idec ($BIIB) helps sell the therapy. To get a biosimilar to market, however, generics players must clear a gauntlet of regulatory, development, manufacturing and marketing obstacles. And the upfront investment in the programs can easily dwarf the expense of a small molecule generic before it hits the market.
“This is not for the faint of heart,” Jeff George, head of Sandoz, told Reuters earlier this year.
Right now, it’s starting to look like the major providers of original biologics such as Amgen ($AMGN) and Biogen could have an upper hand in the market. Both those biotech giants have biosimilars partnerships and have all the requisite expertise to compete with and even beat rivals in this game.
The news about Celltrion’s dropped trial comes amid reports about the company’s chairman and CEO, Seo Jung-jin, seeking a major pharma company to buy his controlling stake in the company, The South Korea Times reported. Now that the company’s Rituxan biosimilar is at least on the ice, I’m even more interested to find out which “multinational” pharma group is in the market for the controlling stake.
Tags: ACI Event, biosimilars, pharmaceutical manufacturers
No Comments »
ACI’S Summit on Advertising Privacy Compliance: Mobile Apps, Smart Phones & the World Wide Web
May 31st, 2013
in Advertising & Marketing |
In an Era Where Advertising is Moving Increasingly Toward the Digital Sphere, Ensure Your Company Remains Competitive and Compliant Washington is Watching You – Are You Watching Your Consumers?
When: Tuesday, June 4 to Wednesday, June 5, 2013
Where: The Carlton Hotel, New York, NY
For more information, and to register: Click Here
Industry News
Industry related article from MediaPost.com, by Mark Walsh, posted on 05/ 07/13:
As marketers become more familiar with location-based targeting, they are shifting from geotargeting to more precise methods for reaching mobile users on the go.
The share of national brand campaigns using “geo-precise” techniques such as geo-fencing or targeting based on location-specific consumer behaviors increased to 58% in the first quarter, up from 27% in the year-earlier period, according to the latest report from location-focused mobile ad network xAd. Conversely, the proportion of campaigns relying on geotargeting — including zip codes, cities and DMAs—fell from 64% to 40%.
Run-of-network, which does not include any specific type of targeting, fell to 2% from 9% a year ago.
The 58% share of what xAd calls geo-precise campaigns, however, marked a steep drop from 81% in the fourth quarter of 2012, when holiday season promotions drove up the level of location-targeted mobile ads by retailers and brands.
xAd CEO Dipanshu Sharma said advertisers are increasingly attempting to target mobile audiences based more closely on their exact location than wide geographic areas in connection with better results. Its report highlighted a case study in which Pinkberry used a one-mile geo-fence along with search-based behavioral targeting to promote its new “Pinkberrygreek” yogurt with $1 discount and a buy-one-get-one-free offers.
The ads click through to a landing page that is specific to the nearest location as well as options to save the coupon presented, get the address, phone number and map and directions. Within the first two weeks, the yogurt chain said the effort had doubled the benchmarks it set for the campaign.
xAd noted in its report that while geotargeting is commonly used in desktop advertising as a way to raise local market awareness, the approach is less effective in driving immediate online or offline actions, like luring people nearby to a Pinkberry with special offers.
The company says its location-targeted ads overall perform better than the industry average for either targeted display or search, at 0.6% to 0.5%, and 8% to about 5%, respectively. But it said that its highest level of location targeting also carries higher-than-average CPMs.
When it comes to industries using mobile-location ads, financial services/insurance, telecommunications and restaurants were tops in the first quarter. That’s fairly consistent with 2012, except that financial services moved ahead of telecom into the No. 1 slot, and restaurants replaced travel. Other top categories in the quarter included health and beauty, auto and retail.
The south, which has the highest proportion of smartphone users (38%) and tablet users (37.3%), continued to be the region most heavily targeted by mobile advertisers, according to xAd. Houston was the most ad-targeted city, followed by Chicago, Los Angeles, Philadelphia and Miami. Five of the 10 cities most targeted by marketers were in the south.
The findings are based on xAd’s network and campaign data spanning 200 brand campaigns from January through March. The company’s network reaches about 100 million mobile users a month, or almost three-quarters of the U.S. smartphone audience of 137 million.
Tags: ACI Event, Advertising, Advertising Law, Compliance, Privacy, xAd
No Comments »
Christie Grymes Thompson
May 31st, 2013
in Advertising & Marketing, Expert Guest Blog Entries, Legal Conferences |
Biography
Christie Grymes Thompson is a partner in the firm’s Washington, D.C. office and chair of the Advertising and Marketing and Consumer Product Safety practice groups. She focuses her practice on consumer protection matters, including advertising, product safety, competitor challenges, and promotions. Ranked nationally as a leading practitioner in the Advertising: Transactional & Regulatory area by Chambers USA, sources tell Chambers that Ms. Thompson has “outstanding technical industry knowledge” and is “practical, responsive, efficient, and fun to work with.”
Ms. Thompson counsels clients in all aspects of regulatory compliance, with a focus on statutes and regulations enforced by the Consumer Product Safety Commission (CPSC), Federal Trade Commission (FTC), and state Attorneys General.
Ms. Thompson helps companies identify and resolve potential product safety issues confidentially before they escalate and have the potential to draw scrutiny from regulators and negative publicity. She advises clients to ensure that products on the market meet applicable safety standards, including complying with the Consumer Product Safety Improvement Act (CPSIA), the Consumer Product Safety Act (CPSA), the Federal Hazardous Substances Act (CPSA), the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), and the Flammable Fabrics Act (FFA). This work includes developing product safety compliance programs, analyzing potential reporting obligations, coordinating with other parties in the distribution chain, implementing product recalls, defending against enforcement and penalty proceedings with the CPSC, and responding to Freedom of Information Act requests. Having represented a broad spectrum of manufacturers, distributors, and retailers of consumer products, including electronics, fire and security systems, outdoor power equipment, children’s and nursery products, and clothing, Ms. Thompson’s work before the CPSC and on behalf of clients is extensive and varied.
Ms. Thompson also handles various phases of marketing products. She reviews advertisements and marketing materials for all media, including television, print, Internet and telephone, to determine compliance with relevant regulations and the risk of challenge from regulators, competitors, or consumers. Ms. Thompson challenges competitors’ advertising before the National Advertising Division (NAD) of the Council of Better Business Bureaus and in federal court. She responds to inquiries and complaints from regulators, competitors and consumers.
Expert Articles
- Mandated Compliance Program as the New Normal? Williams- Sonma Agrees to $987,000 CPSC Civil Penalty & Comprehensive Compliance Program
- CPSC Imposes Another Six-Figure Civil Penalty
- White House Nominates New CPSC Commissioner and CPSC Adds Director of Compliance and Field Operations
Contact Christie Grymes Thompson
- Email Address: Email Me
- Blog: http://www.adlawaccess.com/
- Website: http://www.kelleydrye.com
Tags: Advertising Law, bio
No Comments »
“Should an EMR App be Regulated?” and Other mHealth Considerations
May 28th, 2013
in Expert Guest Blog Entries, Healthcare |
Expert Article by Matthew A. Kaminer
Before I provide some background—and recommendations—regarding the regulation of mobile health (mHealth) apps, be they drug lookups, electronic medical records (EMR) or otherwise, let me begin with one statement: The U.S. Food and Drug Administration (FDA) regulating and defining mobile medical reference apps is like an agency regulating calculators because long division exists. The FDA regulates an action that’s completed with greater accuracy and ease electronically vs. the traditional written format.
Okay, now that I’ve got that off my chest, on to the topic at hand.
Based on the FDA’s Draft Guidance for Mobile Medical Applications, it is clear that the agency intends to regulate any app that qualifies as a “device” under current FDA regulations, and is an “accessory” to medical devices, or transform a mobile platform into a medical device. Some clear examples: diagnostic imaging apps, blood glucose monitoring apps and apps that monitor a patient’s vital signs.
It is also clear from the Guidance that electronic medical textbooks, apps that automate general office operations and EMR apps will not be regulated as mobile medical apps… yet. I say “yet” because the FDA has stated it may revise its position as it figures out this thing called “technology,” as it’s used in medical practice.
Despite these examples, and two years of industry discussion following release of the Guidance, mHealth companies continue to have plenty of questions regarding the FDA’s regulation of certain mobile medical apps. Recent FDA hearings have provided some clarity regarding specific categories of apps that will or will not be regulated, but there are still some gray areas regarding regulating accessories to medical devices, an app’s intended use rather than its function, and clinical decision support tools. Based on the general language set forth in the Guidance, a staggering number of apps are likely to fall within the FDA’s purview.
For example, if the FDA regulates those apps that serve as clinical-decision support tools (that essentially collect information and convert into a patient-specific result), the Epocrates mHealth application could ultimately become subject to FDA regulation. Why? Merely because the app automates a calculation that could be done by a physician with the use of pen, paper and medical reference materials. Without clarification by the FDA, we believe the Guidance could result in the regulation of mere information delivered via technology.
At a recent event hosted by the American Conference Institute entitled “mHealth and Wireless Medical Technology,” I outlined recommendations for the FDA that would eliminate both confusion and delay, as they seek to regulate medical mobile applications:
- Regulate the Function, Not the Category
Don’t determine which tools to regulate based on the name they’re given (such as a ‘clinical support tool’). Focus instead on regulating based on the functions that each app provides. This will avoid the regulation of apps that merely provide electronic access to a service that’s already available (and unregulated), such as the Epocrates core app.
- Create a Flexible Framework Based on Risk Profiles
Regulate those apps that pose a high risk to patients, review apps that pose a moderate risk and do not regulate apps that pose a low risk.
We believe our recommendations will create an approach that’s beneficial for mHealth developers, physicians and patients, one that will enable innovation to provide health care professionals the right information, at the right time, at the point of care.
For Upcoming Healthcare Events: American Conference- Healthcare
