In my last blog, How to Securely Collect Data for Personalized Medicine, I discussed risks and safeguards for how to collect data for personalized medicine. The next step in the information lifecycle after collection is use, and I’ll focus on privacy and security concerns, risks and solutions in the use of sensitive data for personalized medicine.

 

During the collection phase a blood / saliva sample is typically acquired from the patient. Sample(s) are then sequenced to create the raw genome sequence data.

 

The raw genome sequence data for the patient is then compared to a typical raw genome data baseline data set to create a variance file, or a data set with points of interest where the patients raw genome deviates in interesting ways from the baseline. This raw genomic sequence data set can be very large, ranging to more than 3GB in size. Genomic databases can also contain tens or hundreds of thousands of raw genomic data sets. Maintaining security with such large data sets requires special attention to performance. Examples include hardware accelerated encryption, for example with Intel® Advanced Encryption Standard – New Instructions (AES-NI). Such hardware acceleration can be used in the high performance encryption of databases such as InterSystems Cache.

 

The variance file may then be annotated to attach meaning to the points of interest where they have been correlated with known conditions or traits, perhaps an increased propensity for a specific disease, or for pharmacogenomics where a specific point of interest in the variance file is associated with increased efficacy or toxicity of a given medicine.

 

Lastly, a risk factors report is produced from the annotated variance file and may be used by the healthcare professional to deliver personalized medicine.

The risk factors report may then be attached to the electronic health record (EHR) for the patient.

 

Clearly there are several data sets through the use of sensitive data in personalized medicine, from the raw genomic sequence data, to the variance file, risk factors report and patient EHR, and these need to be protected in confidentiality, integrity and availability.

 

Healthcare organizations using genetic information must constrain their use of this data to usage(s) specified in the privacy notice given to the patient prior to the patient granting consent to use their genetic data.

 

On the regulatory front, the Genetic Information Non-discrimination Act (GINA) prohibits the use of genetic information from any of these data sets by group health plans and health insurers for the purpose of denying coverage to a healthy individual or charging that patient higher premiums based solely on a genetic predisposition to developing a disease in the future. Genetic information is also considered Protected Health Information (PHI) and an organization using genetic information may be subject to the Health Insurance Portability and Accountability Act (HIPAA).

 

For healthcare organizations using genetic information in the United States, the Health Information Technology for Economic and Clinical Health (HITECH) Act requires organization subject to HIPAA to report data breaches affecting 500 or more individuals to Health and Human Services (HHS) and the media, in addition to notifying the affected individuals. Many states now also have breach notification laws, for example California SB 1386 requiring notification of affected individuals in the event of a breach of their sensitive information, which would include PHI such as genetic information that could be associated with them (was not de-identified).

 

Recently, the HIPAA Omnibus Rule became effective and includes further changes to when healthcare organizations must report breaches, together with new requirements Business Associates to comply with HIPAA Security and HITECH Act breach notification rules, holding them directly accountable for doing so. Business associates may include data processors that use genetic information in providing services to healthcare organizations. Disclaimer: this is publicly available information and not a legal summary or advice about regulations.

 

Personalized medicine use of sensitive data may also involve sensitive Intellectual Property (IP), especially in algorithms and knowledge bases used to analyze and assign meaning to genomic data. This IP must also be protected.

 

What types of privacy and security challenges and solutions do you see with the use of sensitive data for personalized medicine?

There’s essentially a 1-in-5 chance that a Medicare patient will be readmitted within 30 days of being discharged from a hospital.

 

The U.S. government estimates $17 billion USD a year could be saved by preventing unnecessary readmissions through better care coordination, not to mention the improved quality of life and lowered infection risk for patients who don’t have to go back to the hospital.

 

Under new federal rules, hospitals with readmission rates considered too high now carry risk of having portions their Medicare reimbursements withheld.

 

The hospital discharge summary is an important document to aid communication that can prevent unnecessary returns to the hospital. If incorporated into an effective workflow, it helps open a window of opportunity for patients and their normal care teams to get on the same page with the hospital on next steps, such as making follow-up appointments, monitoring to prevent complications, managing a new medication regimen, etc.

 

So, if each hospital creates a better discharge process, we will tackle the readmission problem, right?

 

Not entirely.

 

The problem, especially in metropolitan areas, is that patients go to several providers, and a few different hospitals. Therefore, the needed care coordination cannot be confined to one hospital alone. It needs to be spread across the community, including the patient, the patient’s primary care provider, specialists, and in some cases, non-traditional health workers. And to do that efficiently, communities need to standardize the discharge document as well as some targeted post-discharge interventions.

 

That’s the fundamental premise behind an important project that a small Intel team joined in the metropolitan area of Portland, Ore.  We were honored to work with a team led by Melinda Muller, MD, of Legacy Health, who directs a pilot to standardize the discharge summary and process.

 

We describe the project and its initial lessons in a new whitepaper: Developing Community-Based, Standardized Hospital-Discharge Summaries.

 

There are other efforts all over the world to improve the discharge summary process. We’re interested in your thoughts.

 

What’s happening in your community?

It’s vividly educational to pitch in on the front lines of a grand challenge like the Oregon Experiment, sometimes described as “ACOs on steroids.”

 

• How do you take a financially strapped program (i.e., Medicaid), nearly double its size, control its per capita cost growth, and deliver better care and service to its patients?

 

• How do you create more cost-effective clinical workflows across organizational boundaries among traditional competitors?

 

• And how do you use IT to support the program’s lofty goals?

 

Observers of the movement toward accountable care organizations (ACOs) will look to Oregon for evidence of success or failure. To be fair, it will take a few years to defensibly answer these fundamental questions.

 

What we can say definitively now is that the journey is as necessary as it is fascinating. We describe it in a new white paper, ACOs on Steroids: Why the Oregon Experiment Matters.

 

Health Share of Oregon is a lean startup organization that administers a Medicaid transformation project involving several healthcare providers and public agencies in metropolitan Portland.  Health Share of Oregon’s broad ambitions, as well as its birthing pains, demonstrate the opportunities and barriers to healthcare transformation efforts that go beyond tinkering at the edges.

 

I’d like to recognize the great work of Intel colleagues Stephanie Wilson and Prashant Shah, who dug in with Health Share of Oregon’s IT team for about nine months to help get the project started under very tight deadlines. We learned a lot and felt honored to work together with the Portland area health IT community.

 

In healthcare, it’s the long haul that matters. Although the startup phase may perhaps be the most exciting, the ultimate success of the project will be determined through the ongoing hard work to continuously improve. It will take the whole community of Medicaid providers, IT professionals and health data experts to answer the grand questions of the Oregon Experiment.

 

Our thanks go out to the whole Health Share of Oregon community for their efforts to create a safer, higher-quality and financially sustainable system for people with lower incomes and barriers to healthcare access.

 

Because of the Medicaid expansion under the Affordable Care Act, the federal-state program is in need of healthcare leaders and IT professionals willing to innovate.

 

Do you see innovations happening in your community? What’s working and what’s not working?

 

We have all heard the term “big data” more than a few times over the past two years. There’s little doubt that large amounts of relevant information put to good use and analyzed—otherwise known as clinical analytics—has the potential to improve both the delivery of care and the health and wellness of individuals.

 

That’s why we are excited about an upcoming policy forum on June 25 at the Bipartisan Policy Center in Washington, D.C., that will explore the promise, challenges, and policies that are critical to encouraging innovation in improving health and health care through the use of big data. During the forum, two key policy areas will be explored in detail: (1) the role of standards in aggregating and effectively using large, disparate data sets, and (2) addressing concerns about privacy and security of patient data for clinical and research purposes.

 

The lineup of participants is top-heavy with thought leaders from both the federal government and industry who will share their perspectives. Eric Dishman, general manager of the Intel Health and Life Sciences group, will participate in the discussion as will representatives from the Centers for Medicare and Medicaid Services, American Cancer Society, state of New York, and Healthcare Leadership Council. Sen. Ron Wyden (Ore.) will deliver the keynote address.

 

The forum is available to view via a live webcast starting at 8 30 a.m. on June 25. We encourage you to join the discussion and learn more about big data in healthcare by tuning in. Listen to the above podcast that features a conversation with two of the forum's participants: Eric Dishman of Intel and Deven McGraw from the Center for Democracy & Technology.

 

What questions do you have?

China, like the rest of the world, is dealing with a massive aging population. Add to this a rising middle class migrating to the cities and a changing family structure and the stresses to China's healthcare and social services systems are huge. China's government, recognizing these challenges, has provided leadership in its 12th 5 year plan outlining policies and funding providing for technology enabled aging services. 

 

I recently attended the China International Senior Services Expo in Beijing. This conference, sponsored by the Chinese Association of Social Welfare (CASW) under the Ministry of Civil Affairs (MOCA), was a combination of policy articulation and technology and service vendors offering health, wellness, spiritual, and housing solutions. In fact, Intel is working with the Chinese government on an Aged Friendly City Initiative and you can read more about this innovative venture in a new white paper.

 

As I walked the floors of this expo, I was struck by the innovative and comprehensive set of technologies and solutions on display. There were:

 

• Smart phone applications for medication reminding, calendaring and caregiver communication 

• Community-based remote patient monitoring solutions (vitals, weight, video conference); some standalone but many that provided call centers for consultation

• Many different shapes and sizes of Win8* touch and Android based mobility solutions

• Wearables (e.g. watches) that track wandering or aid with fall prevention and emergency response

• Real estate companies who were providing assisted living facilities as well as group vacations and other services for elders. 

 

What surprised me the most was not the Chinese uniqueness of these solutions, but the commonality of need. I could have been in any country, speaking any language. These needs are the same experienced by countries all over the world who have aging populations.

 

The unique aspect in China is the magnitude of deployment occurring. Many of these vendors claimed deployments in the "thousands"...still a tiny fragment of the Chinese market but significant nonetheless. It made me think that China could be the place that gets this right. It has all the elements: the need, the urgency, the policy, the funding, and the innovation.

 

Remember to check out this white paper on the Aged Friendly City Initiative.

 

What do you think?

For the past 12 years or so, San Francisco-based MedAmerica has relied on a web portal to keep doctors in touch with other physicians and clinical staff. More recently, as the BYOD trend has helped define mobile use in the healthcare space, CIO Nancy Burghart-Hall and her team have been busy rolling out an in-house mobile app aimed at streamlining time sensitive communications among the physician practice management group’s 2,000 providers, who span 125 locations across nine states.

 

“Our strategy has been to manage communications among clinicians, who are located inside and outside of the hospital, as part of an overall mobile strategy,” Burghart-Hall says.

 

Launched in 2012, the HIPAA-secure mobile app enables communication among providers via email, voicemail, and text. It also grants access to work schedules—so physicians and clinicians can swap shifts on the fly, if necessary—and a MedAmerica directory with contacts for anyone in the organization.

 

With 1,500 downloads to date, Burghart-Hall feels the app’s uptake is going very well.

 

“Now, we want to extend it to the physicians and the communities in which we practice, to the on-call panels at the hospitals, the specialists and consultants, so that our ER doctors can talk directly, in a HIPAA-secure fashion, about a case,” Burghart-Hall says. “We’re getting ready to look at how we can include those providers in our panel groups, and allow them to download our app and use it as well.”

 

For Burghart-Hall, perhaps the biggest challenge associated with this project has been determining how much to invest, given that MedAmerica’s provider population is approximately 50 percent over (and under) the age of 40.

 

The current generational transition taking place may suggest IT is driving the adoption of technology before the other half of the physician population is ready to adopt it, but Burghart-Hall is striving for “an acceptable balance” that promises to both improve quality of care and increase efficiency.

 

Going forward, the IT team plans to bolster MedAmerica’s mobile app by partnering with another vendor that has a national provider directory. Such a move would greatly expand the expertise available to the physician practice management group’s ER doctors. However, the challenge here is the same as that experienced by anyone trying to exchange health information: knowing who’s on the network at all times.

 

Burghart-Hall says she’ll consider the project a success when providers report they’re able to communicate electronically—and efficiently—in a HIPAA-secure fashion. For the time being, though, she’s focusing on extending the app to MedAmerica’s communities.

 

What questions do you have?

 

As a B2B journalist, John Farrell has covered healthcare IT since 1997 and is Intel’s sponsored correspondent.

Below is a guest blog from Narayan Sundararajan, global healthcare program manager at Intel, who attended last month’s Global Midwifery Symposium.

 

Think about this: pre-eclampsia/eclampsia, post-partum hemorrhage and prolonged and obstructed labor together account for more than 50 percent of all maternal deaths in developing countries. That’s why the Second Global Midwifery Symposium in Kuala Lumpur last month was so important for introducing strategies to strengthen healthcare in developing regions.

 

One of the biggest strategies is introducing technology to the process.

 

A workshop that Intel participated in with UNFPA, WHO and JHPIEGO launched three key e-learning modules for training frontline healthcare workers and midwives on life-saving skills. The energy, passion and vibe from the participants during the training and workshop was tremendous; they all really want to make a positive difference in the world.

 

During the session, around 70 midwives, frontline health workers and others from more than 25 countries were trained on how to use the skoool™ healthcare education platform. The open access, no charge license e-learning application can be used both offline and online, and can house various types of content formats including the three modules on pre-eclampsia/eclampsia, post-partum hemorrhage and prolonged and obstructed labor with associated quizzes.

 

Each participant’s laptop was loaded with the platform and modules to take back to their respective countries. The sponsoring organizations challenged each of them to see how they could incorporate such a platform and modules in their own country’s health system to bridge the gap between lack of facilities and trainers and critical shortage of health workers.

 

In addition to the workshop, I gave an overview presentation on innovations as strategies and made the following key points:

 

• Innovation is defined as something new, fresh or improved but that creates value. And, it is important to understand where your innovation falls in the spectrum of incremental, modular, architectural or radical innovation and what the value it creates is.

 

• Doing that is not just a theoretical exercise but allows self-introspection on its novelty, the potential impact it will have and most importantly, the obstacles or roadblocks that will be faced and need to be overcome for its successful implementation and scaling.

 

• Traditionally, governments and development agencies are more comfortable with incremental innovations whereas more examples of radical innovations are found in the private sector. Hence, public private collaboration is a key to encouraging radical innovations that have tremendous impact.

 

A four-way collaboration between Intel, UNFPA, JHPIEGO and WHO is an example of a radical innovation that has the power to transform healthcare access, quality and cost as it exists now and in particular, revamp healthcare education and training as it is delivered today. That’s why innovation is no longer a choice, and applying technologically innovative solutions to address big problems in maternal and child health is an imperative.

 

What do you think?

 

At HIMSS 13, Craig Spencer, director of mobile clinical computing at Dell, explained how mobility has always been important in healthcare and how best to accommodate the Bring-Your-Own-Device (BYOD) trend among clinicians. His suggestion is making sure the data is secure by using features such as multifunction authentication steps (like security cards), biometric readers, and full disk encryption. 

 

Watch the above video to learn more, and let us know what questions you have.

Dr. Lyle Berkowitz, associate chief medical officer of innovation for Northwestern Memorial Hospital, believes that failure leads to innovation. His book, Innovation with Information Technologies in Healthcare and organization, Szollosi Healthcare Innovation Program, offer proof that innovation must be nurtured and that it often occurs under surprising circumstances. Read below in this 5 Questions interview for his insights and advice on making healthcare organizations more in tune with innovation.

 

Intel: What are three simple things an organization can do to encourage innovation? Dr Lyle pic.jpg

 

Berkowitz: The key is to change the culture of the organization, which needs to be both top down and bottom up. From the top, the first step is to get executive buy-in that failures are a good thing. An innovation mantra is fail fast, fail often and fail cheap…you will always learn a lot! So many hospital executives are scared of any failures, but they need to be embraced to encourage people to try new things. Second, identify someone whose role is to find new innovations for piloting and to support innovators within your organization. Give this person a small budget so they can try new things without having to go through the usual budget bureaucracy, while also recognizing that their job is to move from concept to pilot to figure out if a bigger project is warranted. Finally, consider an X-prize or crowdsourcing exercise in which your whole organization is challenged to come up with an idea that can create significant value.  If you promise to split any cost savings with the winners, you will likely be shocked with how many good proposals you will get!

 

Intel: Your book, Innovation with Information Technology in Healthcare, collects stories from more than 20 organizations that have successfully created and implemented new health care information technology processes. What is the common denominator across all of these successes?

 

Berkowitz: Our book allows the innovators themselves to tell us what they did, why they did it, how they succeeded, lessons learned, and their plan for next steps. It's like a big cookbook of recipes on how to innovate, with sections on EMR Innovation, Telehealth Innovation, and Advanced Technology Innovation (e.g., analytics, portals, mobile, and gaming). Some commonalities include having a physician or other champion with a passion for fixing something that is not working well, the patience for multiple iterations, and the skills to start something small and then expand it once it starts succeeding. Additionally, many of the stories focus less on the technology, and more on the process, business model, and sometimes legal changes needed to realize the full power of the innovation.

 

One of my favorite stories in the book describes how UPMC addressed an issue involving a patient who came in for antibiotics, but had a severe allergic reaction to the latex gloves used by the IV team. Although she had a known latex allergy, the IV team was not aware of this because it was not part of their workflow. Instead of simply saying, "We can improve this process by making the IV team always check for latex allergy,” the executives decided to do a brainstorming session and used this example as a starting point for how they might rethink the whole process of care at their hospital. Someone came up with the wild idea of "What if the room was alive and knew who entered and what information they needed based on their role?” That idea became a prototype involving a monitor and computer system, which used RFID to identify who entered a room, and then displayed relevant information and allowed them to enter data. The team found that this improved both quality and efficiency, and they wound up creating a company to deploy these at their hospital and beyond. It represented the whole arc of innovation—problem to brainstorming to piloting to spreading. Other stories describe how an EMR’s built-in functionality can be used to support care coordination, preventive care and disease management, and early warning for adverse events. Telemedicine stories range from traditional doctor-patient video calls to electronic curbside consults to ePharmacists and Teletranslators. And, finally, there is a section describing the use of analytics, mobile, and gaming technologies applied to healthcare.

 

Intel: What healthcare technology do you use and like?

 

Berkowitz: From a personal and business perspective, I loved my smartphone from the second I got it. It's critical for me to keep in touch with my email as I juggle multiple roles and travel away from my office several times a week. However, with respect to clinical care, my technology needs are different. I need a large-screen computer. I use an electronic medical record system and a secure messaging system to keep in touch with patients. I access UpToDate for most clinical reference, and use Google in the exam room when I need to show a patient a picture or video to get a point across. We also have a nice touch-and-go authentication system, and more importantly, for security is a system that locks my computer when I open my exam room door to leave.

 

Intel: How do you see healthcare technology changing in the next three years?

 

Berkowitz: I think there will be two major changes for healthcare.  First, I think the EMR will become more of a platform and we will see "EMR Extender Companies" building apps that sit on top or alongside EMRs to improve efficiency and quality in a variety of workflows. A company I cofounded two years ago, healthfinch, focuses specifically on apps to improve physician productivity by helping to automate and delegate certain repeatable tasks away from doctors and toward their staff (e.g., medication renewal requests). Second, I think we will see consumer biometrics get increasingly small, cheap, easy, and ubiquitous. What will then be important is to have a way for physicians to "use" all this data. I envision a future where this ubiquitous health data flows into a cloud that contains the protocols to help promote wellness in all, maintain health in those with stable illnesses, and identify outliers who need to come in for review.

 

Intel: What is the Szollosi Healthcare Innovation Program? What changes are you trying to make within the healthcare system?

 

Berkowitz: The Szollosi Healthcare Innovation Program (SHIP) is a charitable endeavor with a mission to use creative thinking and diverse technologies to produce a better healthcare experience for patients, physicians, and others associated with their care. Our work on care coordination has been highlighted in the Harvard Business Review and by the Hope Street Group. Our work on "information visualization" was highlighted at the Mayo Clinic's Center for Innovation Transform Conference.

 

Two of our care coordination projects were selected for the AHRQ's Innovation Exchange:

 

ExpectED: Electronic Handoff Notes to the Emergency Room

The Inflection Navigator: Tale of an Easy and Effective Care Coordination System

 

The Szollosi Healthcare Innovation Program is trying to help spread the word on the use of innovation science in healthcare to help others think differently about how to address issues we face every day.

 

For more insights, follow @DrLyleMD on Twitter and read his book, Innovation with Information Technology in Healthcare.

 

What questions do you have?

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