Helping Clients Navigate Compliant Communications for FDA-regulated Products

Helping Clients Navigate Compliant Communications for FDA-regulated Products IMAGE_EDVANITY URLS: Google Paid Search Engine Marketing (SEM) Changes
• Redirecting ad changes effective January 12, 2016
• Prohibiting ads where vanity URLs are utilized and dramatically different from the destination URL

Google has announced significant changes in their paid search engine advertising policies with regard to pharmaceutical products. The change that we are addressing here deals with vanity URLs, and their respective redirecting ads, that will take place in January 2016. The bottom line is that Google will no longer allow vanity URLs in an effort to provide consumers with more “clarity and transparency.”

Google has a long-standing policy prohibiting any ads where the destination URL differs dramatically from the display URL. Please note, this prohibition is not exclusively for pharmaceutical products—it has been Google’s practice across the board. Up until now, the pharmaceutical industry had been the exception to the rule. The reason for the exception was because in many cases, information seekers will not know the name of a drug, but will understand and know the symptoms/disease state information.

FDA background information
Previously, the FDA never objected to marketers utilizing vanity URLs and/or redirecting ads. These URLs/ads typically do not directly promote the name of a prescription product. Instead they lend themselves more to a disease state or descriptive nature, and then redirect users to another location or URL where they will see branded information specific to the prescription drug and/or disease state. Vanity URLs/redirecting ads are not exclusive to online SEM use, and are also used in print ads, television commercials, billboards, postcards, and more.
In March 2009, the FDA sent out 14 violation letters regarding search engine marketing practices of 48 brands. Thirteen of those violations referred to SEM ads running on Google. The FDA noted four types of violations in 2009:

  1. Omission of risk information, failure to meet requirements of 21 CRF 202.1(e)(5)(ii)
  2. Inadequate communication of indication
  3. Overstatement of efficacy
  4. Failure to use the required established name

Google’s reaction—what exactly is Google implementing?
Beginning in January 2016, Google will not permit pharmaceutical advertisers to have vanity URLs (such as “”) that redirect users to a website.

Pharmaceutical marketers will have the following options for vanity URLs:
Option 1


Sample ad showing company name as URL

Option 2
They can add “.com” to the company name.


Sample ad showing company name plus .com as URL

Option 3a (for prescription drugs, biologics, and vaccines)
They can display the phrase “Prescription treatment website” as the display URL.


Sample ad showing prescription treatment display URL

Option 3b (for medical devices)
They can display the phrase “Prescription device website” as the display URL.


Sample ad showing device display URL

All of these ads will be able to drive to pages on the or website.

At the present time, this change has been instituted by Google only, and doesn’t lend itself to print, television, or other advertising mediums.

What does this mean for our clients?
Review and reassessment of live and proposed Google SEM campaigns where clients utilize vanity URLs need to be completed as soon as possible. New campaigns need to take these new rules into consideration during the tactical planning phase. Funds can be shifted to Yahoo and Bing, however there is the possibility that they may also follow suit.

Google has indicated a willingness to work with pharmaceutical clients to minimize potential negative impact to paid search campaign performance. Testing of the new formats will determine which type of units work best with various campaigns.

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Does Size Always Matter?

How Pharma Engages With Its Followers Online

Social Network Blog Image_EDPharma is investing more heavily in social media than ever before; tweets are up 530% since 2013 and Twitter followers have increased by nearly 300%. So far, so good. Because more followers means more opportunities to get involved, and the more impact you make online, right?

But engaging in genuine, meaningful conversations about a corporate brand isn’t easy, and it’s important to ensure we don’t fall into the trap of focusing too much on numbers and not enough on engagement. Companies need to ensure they don’t build followers just to push out messages to anyone willing to pay attention. While people are increasingly more open to finding new knowledge on social media, they don’t want to wade through hundreds of pages of information, images or tweets to do so.

The balance between community size versus engagement is becoming more and more of a priority, and formed one of the focus areas for a recent report published by Ogilvy Healthworld, part of Ogilvy CommonHealth Worldwide (the health behavior specialists of Ogilvy & Mather).The report, Connecting the Dots: Which Pharma Companies Are Succeeding in the Social Media Space?, was the first of its kind to provide insights into which pharma companies are leading the way in integrated social media marketing strategies.

“We know that some pharma companies have been cautious in their approach to social media, but our report clearly demonstrates a dramatic and successful increase in activity,” said Rebecca Canvin, Social Media Manager at Ogilvy Healthworld, adding: “Social media has changed the way pharma companies communicate—it allows them to build corporate reputation and engage in genuine, meaningful conversations with audiences. For companies who want to stand out from the crowd, it’s time to be brave, get personal, educate and integrate social media into their wider marketing strategy.”

Interestingly, companies that ranked most highly in the audit weren’t necessarily those with the largest communities, but those who engaged their audiences through frequent activity. And it’s not hard to understand why the more active companies enjoy the most engagement with their followers—after all, social media in its very nature demands participation and interaction. But the companies that do it well manage to create content that is less about the organization and more about connection points or interests that followers share.

The report highlights that although the focus for pharma companies is still on building brand profile, the priority is turning to attracting, keeping and engaging with loyal followers. And to do this, the onus needs to shift to “quality over quantity.” It’s more powerful to engage with a small group of passionate followers, whether they’re consumers, doctors or media, than to blast one message to 10,000 followers and “see what sticks.”

And loyal followers will reward companies who engage continuously in this way—so really, shouldn’t we all be asking, how much does size matter?

Connecting the dots - infographic UK Post

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Google Changes Search Ad Format For Pharma Brands

Search-For-PharmaGoogle has announced that it will be updating the Google Search ad format it offers to healthcare and pharmaceutical brands. This change affects support for pharmaceutical brands with black box warnings and those that require adverse event information as part of the ad.

URL architecture for black box brands

As of July 20, 2015, Google will be moving to a common AdWords format that no longer supports an additional line of copy and additional URL for black box brands and those requiring adverse event language. This is an evolution that is optimized for its paid search marketing solution that has been available to pharmaceutical advertisers for the last five years.

An example of how a brand might be using search engine marketing in Google AdWords before and after the July 20th update:

Pre-July 20th AdWords Example:
Brand Ad 1
Post-July 20th AdWords Example:
Brand Ad 2




What does this change mean for pharma brands?
Brands that are currently using Google AdWords for marketing will need to consider a rewrite of existing creative and landing pages. The pages that the new AdWords ad links to will need to prominently feature adverse events information for the product. This will require revisiting of search marketing strategies as well as potential user experience and design changes to optimize inbound traffic from paid search campaigns.

Brands currently using paid search programs with Google should leverage Google’s Sitelinks feature, which provides several links to content within a product website within the AdWords format. Product managers and agencies should also reinvest in paid mobile search with this change, as there is a broader efficiency with this change in having a single ad format for all platforms (desktop and mobile search).

Post-July 20th AdWords Example with Sitelinks:
Brand Ad 3

The changes to Google’s AdWords program will have a significant impact on pharma brand website marketing performance as well as the cost of paid search solutions currently used for search engine marketing programs. Expect to see changes in your category as well as behavioral changes for your paid and organic search performance.

Next steps
The changes to Google’s AdWords program will affect every brand using paid search for healthcare professional and consumer engagement. Work with your agency partner to identify the best counter-measures for these changes and how to recalculate your performance metrics.

Ogilvy CommonHealth offers digital strategy, content strategy, creative development, and analytics services for all of our clients to guide brand leadership through these and any future changes to search engine marketing and market changes in digital and traditional media.

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Wearable Wonder: Will They Improve Patients’ Quality of Life?

LeanneLakeBlogImageSizedClearly wearables are “all the buzz” in our industry. Soon our Fitbits, watches and the like will become an essential part of connected healthcare, monitoring our bodies and feeding important data about our health to the cloud to be analyzed by our healthcare professionals. More data in, better outcomes come out—it’s fantastic news. But what if these devices can go the next step and actually respond to the data they are monitoring? Can you envision a future where a wearable device can improve our body’s function and a person’s quality of life in real-time? I recently learned about one that just might.

It’s called the WAK, short for the Wearable Artificial Kidney. This wearable innovation has the potential to be truly life-changing for the more than 400K patients with end stage renal disease who are currently undergoing hemodialysis every day in our country.

For the majority of these patients, treatment is their lifeline, but it can also take over their life. Hemodialysis patients receiving treatment in centers spend on average 4 hours a day, 3 days a week completely immobile—tethered to a chair, tied to a machine. Much like chemotherapy, the treatment that is saving them often makes them sick for hours afterward. In the absence of a successful transplant, they will undergo dialysis until the end of their life.

The WAK is designed to help patients get out of the chair and back into life. It is a miniature battery-powered dialysis device that is worn like a tool belt. It is connected to the patient by a catheter, weighs approximately 10 pounds and offers dialysis 24/7. Some experts believe that in a perfect world, more frequent dialysis would yield better control, however this comes with a tremendous burden to the healthcare system. If proven successful, the WAK could improve outcomes and deliver new hope for patients, reducing their time in the chair and giving them the mobility to go about activities of daily life—a more “normal” existence. The FDA fast-tracked the WAK, and it is currently undergoing its first human trial in the United States. Human clinical trials conducted in Italy and London already concluded successfully.

For me, following the progress of this wearable technology is personal. I lost my dad to end stage renal disease and its complications three years ago this June. During the five years he “survived” on dialysis, I watched his body and spirit wear thin. Early on, the dialysis center gave him the personal connection he needed to share with patients having a similar experience, but soon after getting into the three-day-a-week routine, he and my mom longed to get back the flexibility that every retired person deserves. The ability to hit the driving range with his buddies on a Tuesday, attend his grandson’s football game on a Thursday, or even make the trek to NJ to visit me and my family on a Saturday afternoon.

Looking back, I wonder how the WAK would have changed my dad’s dialysis experience and the burden it placed on both him and my mom.

What’s your wearable wonder?

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ResearchKit: A Medical Research Revolution?

Research Kit Blog Image SizedIn what boils down to crowd-sourcing medical information, Apple’s ResearchKit promises to turn the iPhone into a powerful tool for medical research. But will it live up to that promise?

Apple is putting the power of clinical trials in our pockets with ResearchKit, the open-source software framework designed for medical and health research. It will help doctors and scientists gather data more frequently and more accurately from clinical research participants using iPhone apps, enabling faster insights at lower cost.

ResearchKit leverages the sensors and other capabilities of the iPhone to track movement, take measurements and record data. When granted permission from the user, ResearchKit can access data from Apple’s HealthKit app such as weight, blood pressure and glucose levels, which are measured by third-party devices and apps. ResearchKit can also request access from the user to access the accelerometer, microphone, gyroscope and GPS sensors to gain insight into a user’s gait, motor impairment, fitness, speech and memory.

Several world-class research institutions have already developed apps with ResearchKit for studies on asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease. Using the built-in templates for informed consent, users decide if they want to participate in a study and how their data—and which parts of their data—is shared. Participants can perform activities and generate data wherever they are, providing more objective information than simply filling out forms for their activities.

More data will be generated through these apps for researchers to analyze than ever before. For example, just four days after its release, Stanford University School of Medicine’s MyHeart Counts app was downloaded 52,900 times, with over 22,000 users consenting to the study. But more data isn’t necessarily better data.

On the surface, ResearchKit sounds like the long-awaited answer to ongoing issues in traditional clinical trial processes, including limited participation due to proximity to institutions running trials, frequent data entry and the integrity of that data and limited data collection.

Apple has created three customizable modules to address the most common elements across different types of clinical studies: surveys, informed consent and active tasks. Programmers can use these modules as they are, build upon them or even create new modules of their own.

ResearchKit initially includes five active task modules that invite users to perform activities under semi-controlled conditions, while iPhone sensors actively collect data. The tasks can be a simple ordered sequence of steps or dynamic, with previous results informing what is presented. In this way, researchers and programmers can create custom apps for their relevant disease states. These modules simply record the data and pass it on to the researchers; Apple does not store it or track it in any way.

Since ResearchKit resides on the iPhone, it will be easier to recruit participants for large-scale studies, accessing a broad cross-section of the population. The data that it collects mostly comes from sensors and other apps; there is little chance of error in the measurements as compared to patients recording their data in paper-based diaries. Even the data that patients will enter themselves into ResearchKit apps will be more accurate: programmers can put limits on that data so that it fits within proper parameters.

Although ResearchKit solves many issues with clinical trials, it also creates some of its own.

Patient population

Apple promises access to a diverse, global population through ResearchKit, but that population might not represent the population as a whole.

IPhone users are more wealthy and educated than the general population, and minority groups are underrepresented in its user base. Additionally, ResearchKit is only available on iPhone 5 and newer models and the latest generation of iPod touch, which excludes a large segment of iPhone users.

On top of that, the patient populations for ResearchKit apps will be largely self-selected: those using the apps are already likely to be interested in their own health. So can the results generated from this narrowly defined population be extrapolated to the population as a whole?

Another point to consider with the self-selected patient population is that app desertion rate can be high, so researchers won’t have complete data from those who don’t finish the trial. This will also bias the data toward better outcomes since those who actually finish the trials are more motivated to see a positive outcome.

Data Validation

There is no validation that participants have a specific condition before they can enter a trial. This lack of verification can further skew the results of the trials. Going forward, tighter controls on who can enroll in each trial by verifying their basic information will lead to better qualified participants and more robust trial data.

Secure Communication

Verifying participants’ information might be hampered by the current lack of secure communication mechanisms between ResearchKit apps and their researchers’ servers.

This is up to the app developers to implement, as is HIPAA compliance and compliance with international research regulations. Even if secure communications are implemented properly by app developers, sharing personal medical information is a sensitive subject—especially with current data breaches. There will likely always be privacy concerns, especially in participants who don’t fully understand how their health data will be used.

Big Data

ResearchKit trials could potentially have hundreds of thousands of participants, each one with the potential to have inaccurate data. How will researchers separate the signal from the noise with such large amounts of data?

Cleaning that data will be a huge job, and further making inferences from that data to the general population could be difficult. Building trust in the trial results in light of the challenges listed here could be an uphill battle with the general public. More thought needed here.

Going forward, simple improvements such as data validation will go a long way toward more qualified patient populations and more robust trial outcomes. But how can ResearchKit be made available to a more representative patient population?

The answer could lie in the open source framework of ResearchKit. Researchers will have the ability to contribute to specific activity modules in the framework, like memory or gait testing, and share them with the global research community to further advance what we know about disease. And since it’s open source, there is the opportunity to expand into the Android realm as well.

On a global scale, Android is the far more popular operating system, and its user base is more representative of the population as a whole. It would benefit these clinical studies if users across platforms could use these apps.

That said, Android has a fragmented operating system with disparate hardware platforms that have differences in their sensors (accelerometers, GPS, gyroscopes), and even in chipsets from device to device. Researchers would have to account for all of these differences and build and test apps across platforms, which is nearly impossible on their limited budgets.

While ResearchKit is not the perfect solution for clinical trials research, it is a good first step, especially when it comes to to clinical trial recruitment, which has been the bane of the healthcare industry for far too long. Results of the pioneering ResearchKit apps—for asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease—will reveal the true utility of such a mobile, global medical research solution.

This article was originally published in Medical Marketing & Media.

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Are You Harnessing the Power of Video in Healthcare Yet?

Young woman with gold fish tankDid you realise that the average attention span of a person has dropped to only 8 seconds? That’s one second less than a goldfish!

Video can combat this. It is a fantastic way to hook people in and capture their attention. Online video is growing so quickly that this is an opportunity that’s impossible to ignore:

  • Views on mobile devices have increased 400% in the past 2 years
  • YouTube is now the second most popular search engine behind Google, with 40% of its traffic coming from mobile
  • 80% of online visitors will watch a video all the way through, compared with 20% who will read a webpage

Patients are being diagnosed via video, surgeons are swapping clips on operation techniques, and, as everyone is rapidly becoming more and more mobile-connected, healthcare knowledge sharing will soon have no boundaries.

It’s likely that for whatever purpose, be it for a symposium or for patient education, your video will end up online, where it will receive the majority of its views. But it’s a noisy world out there, and one rule is key: keep it short, smart, and snappy.

What kind of video content should you choose?

The great news is that there are all kinds of exciting options that won’t break the budget. Think about who the audience is and how they’ll be watching. Are they using a small screen? With or without sound? On social media? Or at a live presentation…could Dr Smith at the back please put his mobile down and watch? (Hopefully if he enjoys it he’ll search for it later online, “like” it and share with his colleagues.)

Explore the different ways to cThe Other Sideonnect with your audience. Enriched video content is great for increasing user engagement, and interactive user-defined storytelling can be a totally immersive experience. It lets you get the right messages to each individual user by letting them click on objects in the video to influence what they see. “Choose a Different Ending” is a beautiful example of a great campaign tackling knife crime that drew immediate response. And another of the best ones I’ve seen recently is The Other Side of Honda.”

Or, if you need to get more complex data across in a way that quickly informs and engages, use an animated infographic to make data come alive. These motion graphics pack a huge visual punch, are bursting with information, and are rapidly becoming key tools to promote branded messages. For a truly multi-layered, fast and constantly moving example with beautiful visual transitions, you can’t beat “STUXNET: The Virus That Almost Started WW3.”

Whatever you want to achieve, remember you’re not alone. We recommend that you use a Creative and Motion team to help you get all those questions answered on the way to making great videos.

Video is a super strategy to stand out from the competition and it’s definitely a healthcare trend that’s already here and set to keep on growing.

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How to Have Your Digital Gadgets and Sleep Too

Haley Dix Blog Thumbnail SmallI am not one to make New Year’s resolutions, but this year I thought maybe I should go back to using a regular alarm clock and turn my digital devices off an hour before going to bed. Recent studies have proven that our beloved electronics may hinder sleep.

Although this resolution could be quite beneficial, I couldn’t help thinking about the following:

“What if I miss a breaking news alert from CNN?”
“What if I don’t respond to a time-sensitive text?”
“What if Beyoncé releases another album on Instagram at midnight?

I guess you can say I have a slight case of “Fear of Missing Out,” popularly known as FOMO. Aside from these hypothetical scenarios, you may find yourself experiencing work-related FOMO. It’s no secret that many of us use electronics to sift through emails or work-related checklists one last time before turning off the lights. Although those 30 minutes at 10 PM on Microsoft Outlook seem harmless, your production of melatonin can be effected. The blue light within electronics can increase brain activity and prevent the pineal gland from releasing melatonin hours before bedtime. This results in your body fighting off the feeling of being tired. While it is advantageous to have your devices on at work to increase alertness, if your goal is rest, blue lights can become the enemy.

So how can we enjoy technology and still gain quality rest?

The idea is gaining momentum worldwide—in 2013, Germany implemented a new practice, discouraging employees from sending work emails after hours, except in cases of emergencies. In 2014, France took to the trend, encouraging employees to turn off their phones and refrain from checking email after their work is complete. Companies such as Volkswagen, Google and Facebook have also made efforts in discouraging late-night email correspondence.

Perhaps we can impose some discipline on our social interactions, but it could be hard to enforce digital abstinence, for example, when you are working on a pitch. But we can still make an effort to promote more healthful digital habits for our teams and ourselves. Perhaps you can set an “email silence” time with your team after jobs are no longer routing for the night. Or insist on a phone call if an emergency arises, rather than constantly trading email. Anything to avoid staring at the blue light into the late hours of the night.

So whether your FOMO is attributed to social or work activities, making a few minor changes can help you enjoy your device and not compromise resting. You may even fall in love with, dare I say, paperback books again in the quest to take small breaks from your gadgets. If so, author Ann Droyd offers a humorous quick read titled Goodnight iPad that could bring a chuckle the next time you see one of your blue-light glowing friends.

If you’re not ready to go cold turkey and find yourself having a hard time being pried away from the phone or tablet, try f.lux. This program can be downloaded to your electronic devices and uses warmer lights instead of blue lights, to help the production of melatonin remain uninterrupted. With this work-around, you may be able to watch episodes of Orange Is the New Black on Netflix, sift through the week’s sports rankings, meander through Pinterest recipes for quinoa, and even pay Microsoft Outlook a visit. Just make sure you and your digital gadgets can say, “Good night.”

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Stories to Tell: Facebook for Health Care Brands

Stories to Tell Facebook for Health Care Brands BLOG Image2We all know Facebook is a powerful storytelling platform for brands. But in health care, FDA regulation and privacy rules often leave us watching our counterparts in consumer marketing with jealousy. A recent example of our work with Hackensack University Medical Center demonstrates not only that health care brands can carry out effective content strategies on social media platforms, it can even be simple to accomplish.

HackensackUMC is consistently rated as the top hospital in New Jersey by US News & World Reports. One particular area of excellence is its nursing program. The hospital is one of just two in the nation to earn the prestigious Magnet nursing designation five consecutive times, representing 20 years of distinction.

Last May, during National Nurses Week, we proposed creating a series of Facebook posts where each day would feature a short story and photo of a HackensackUMC nurse.

The work was minimal: we conducted a 20 minute phone interview with each nurse and asked him or her to provide us with a photo. The response was tremendous: The stories we posted about each nurse quickly became the most engaging content the hospital has ever posted on its Facebook page.

Of particular note, on Wednesday of National Nurses Week, the story of about Dennis Leenig Jr., a pediatric oncology nurse, received over 450 likes, 50 comments and 25 shares. Here’s the post:

It’s not unusual to find Dennis Leenig, Jr. sitting and talking with a patient a half hour after his shift has finished for the day. “Working with leukemia patients, I like that I get to see people through all stages of their care. You get to establish a rapport,” he says. It’s a relationship that continues even after a patient has gone home. Dennis always conducts follow up calls to patients after they’re discharged to see how they’re feeling and to make sure they’re not having trouble getting any medications. “Patients have told me I’m like a son to them and that means the world to me.” Dennis remembers when his own father was a cancer patient at HackensackUMC. A nursing student at the time, it was while visiting his father that he realized his calling was in oncology.

Even more powerful than what we wrote about Dennis, were the testimonials that former patients posted in the comments section. Some excerpts:

Hey Dennis, I remember you well. I felt like I was in expert hands and it was clear to me that your concern for my wellbeing was sincere and genuine. Thank you for making a stressful event a little less so.

We love Dennis and know him well after having many visits to 8PW over the past 4 years with our son. His love and dedication to all patients goes above and beyond. Thank you, Dennis, for all that you do. You have become like family to us.

Dennis, when my uncle was in your care I felt reassured knowing that he had an all-around great guy to help him. He really liked you and spoke highly of you. He fought a good fight but the cancer was too aggressive. I have the utmost respect for what you do on a daily basis and I wanted to thank you again (and the rest of the doctors, nurses, and staff) for everything you did to make his life more comfortable when he was in your care.

The marketing and PR value of these posts is obvious. Who wouldn’t want to go to a place with such compassionate, attentive care? And Dennis was just one of seven nurses we featured that week.

But another benefit of sharing these stories on Facebook is easy to overlook: Facebook as an internal communications tool. The nurses were honored that we thought to interview them for the Facebook page and proud to receive public recognition for their work. And their colleagues enjoyed reading the stories and having a public place to record their praise. It was a morale boost all around.

We are constantly uncovering great stories like Dennis’s. But in this regard, HackensackUMC is not unique. All of our clients’ organizations are brimming with stories.

Maybe it’s easier to find them in a hospital, where nurses are touching lives every hour of every day. But great stories are everywhere–even in corporate settings. What motivated a pharmaceutical company executive to enter the health care industry? Why did a research scientist decide to focus on this particular disease state?

The answers to these questions are personal stories. Telling them brings out the human side of a corporation and pulls employees closer together. New media tools like Facebook make it easy to bring them to the public. And the public is hungry hear these stories from your brand. Especially in health care.

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Responsive Web Design in Pharma

CREATIVE MOBILE BLOG PHOTO2Data is showing that we are using smartphones more and more for everyday items—searches, purchasing consumer products, travel, weather, and World Cup updates, just to name a few.

We also see smartphone users searching on prescription drugs. Healthcare professionals (HCPs) are using mobile more in their practices, yet the branded drug websites are not optimized for viewing on their phones. We see this as a missed opportunity to provide the information need to the device being used.


In the pharma space, we are seeing an uptick with websites moving to a responsive design methodology with consumers—but not with HCPs. We need to understand how HCPs are using their device in the office. By thinking mobile first, we can better serve their needs. Focusing on the user experience with information architecture and content strategy, we can provide the right information to the user, spanning across multiple devices.


This would be extremely helpful for our HCPs. If I need to look up a dosing chart for a specific drug while in the exam room, I should be able to use my mobile device to view and interact with the chart. Later, when moving to the desktop, I should have the same content and experience.


The chart to the left is a good example to see how content can be organized from the desktop to smartphone. Take note of the design grid and how it responds to device screen sizes.


A good example in the pharma space is Forum Pharmaceuticals ( Simple, easy to navigate, and the experience stays with you through the multiple devices. This makes for a happier end user.





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Are Apple’s new offerings really ready for healthcare?

RPBLOGApple fans were waiting with bated breath for this week. And in usual Apple style, the company did not disappoint the vast numbers of people who eagerly sat through a staged presentation of the new products Apple will be foisting upon us in the next six months.

The new iPhone 6 is a sleeker, stylish phone with a bigger screen, a plethora of new groundbreaking apps such as Apple Pay, and powerful technology that could make the phone even more personal than it is now.

And as if that were not enough, Apple provided a double-whammy by showcasing the new Apple Watch, a truly innovative and stylish mini device that will change the simple task of telling the time.

With these two new devices, Apple also began to stake a claim in the health and wellness arena.

Let’s take the phone. It comes bearing the next generation of Apple’s powerful M chip—the M8. This chip enables Apple to turn the iPhone into a fitness tracker. The next generation motion coprocessor and sensor will know whether you’re riding a bike, running, or speed walking. It will also be able to estimate distance as well as how far you’ve gone. Finally, it will track elevation, thanks to its very own barometer, which will pick out your relative elevation by measuring air pressure.

All of this data will be collected by the new HealthKit app with powerful and intuitive dashboards and displays to help the owners of the device to begin tracking and analyzing all manner of activities.

The Apple Watch enters a largely unregulated personal health tracker business, taking on Fitbit, Jawbone, and other wearable devices. This is a powerful device. It is a pedometer, a heart-rate monitor, and it comes with a robust array of fitness tracking features, including “rings” to track your movement.

The Move ring will track your normal amount of activity, such as walking. The Exercise ring will track all manner of exercise routines, and the Stand ring will measure how long you stand or sit during the day.

But the watch also becomes your personal coach and will give you customized reminders to reach fitness goals. It will have its own Workout app, which will measure calories, time spent working up a sweat, and a variety of other activities. Finally, it will also gently nag or encourage you toward doing things more slowly than you planned. All of this will be shared with the HealthKit app.

Apple plans to offer a sports version of the watch, which comes with an alloy case that’s 60 percent stronger than the regular version.

The Apple Watch looks like it will become a serious contender in the fitness tracking market, but the steep pricing may make other fitness trackers more appealing to people.

From a regulatory perspective, the Apple Watch, while not being deemed a medical device by the Food and Drug Administration (FDA), will be watched closely. The personal health data collected by individuals for their own use is outside the federal laws controlling the use of patient information.

This collection of data opens up a debate on privacy, and as this is health-related data, there will be extra scrutiny on how this data is collected and used, and more importantly, who has access to it.

However, the Feds are closely watching this fast-growing market. The FDA has already issued a list of mobile applications it is watching closely. The list includes software used by individuals to track and log personal data on exercise, food consumption and sleep patterns, and to make suggestions about health and wellness.

The major issue for privacy advocates will be how this personal data is used by the device makers and developers of apps. How marketing uses this data for profiling and targeting will become a place for regulators to identify safeguards.

Apple is also doing its bit and has made it clear to developers of health apps that it wants to protect privacy. This comes on the heels of the broadly covered celebrity hacking debacle that occurred a few weeks ago, opening up a debate about the collection and backup of data from mobile devices that synchronize with the cloud.

Last week, Apple updated its guidelines for health app developers, stating that apps working with HealthKit may not use the personal data gathered for advertising or data-mining uses other than for helping manage an individual’s health and fitness, or for medical research.

The guidelines also say that app developers cannot share data with third parties without the user’s consent.

It will be interesting to see how the FDA, as well as privacy bodies in the more stringent and regulated environments in Europe, deal with the brave new world that Apple is forging for us.

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