Mobile Devices Monitoring Hearts

A young female patient over 20 years ago with a severe heart condition underwent one of the first procedures at UCSF to restore normal heart rhythms called AV node ablation, which modifies the electrical pathway that connects the top chambers of the heart to its bottom chambers. At that time, a pacemaker was implanted into her chest.

For years, she had to fly several times a year from her New York home to California for checkups with the medical team at UCSF that performed the procedure to correct her heart rhythms when she was young.

Today, the patient is enrolled in an UCSF-developed online cardiovascular study “Health eHeart Study” that harnesses the power of mobile technology to monitor patients using their smartphones. This makes it possible for the information to go immediately to their doctors and then the patient can obtain instant feedback.  The study funded by the Salesforce.com Foundation aims to enroll one million people from around the world.

According to Jeffrey Olgin, MD Chief of the UCSF Division of Cardiology, hopefully more patients will be able to be diagnosed and treated more rapidly than is currently possible since we are working with a large patient population connected electronically through smartphones.

The apps and certain study-related devices are given free to participants. Olgin and his team plan to analyze the data to identify patterns. This will allow them to not only identify population-based predictors but to also identify deviations from baselines.

“We hope to collect copious amounts of data on a large segment of the population so that we can develop very robust and accurate models to predict the occurrence of heart disease in people who don’t yet have heart disease. We hope to slow the progression in people who don’t yet have heart disease, or to slow the progression in people who already have heart disease”, said Olgin.

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Increasing Bandwidth to 100G

As telehealth becomes increasingly prominent, it is important to have a network that enables the transfer of high broadband applications such as multiple high-definition video streams and EHRs. This is necessary not only for discussion and diagnosis but importantly for education and treatment purposes.

Ciena Corporation, a network specialist recently announced that the Utah Education Network (UEN) selected Ciena to increase their network bandwidth from 10G to 100G and beyond.

UEN serves as the commercial internet and provider of connectivity between internet2, the state government, and the Utah Telehealth Network (UTN).

UEN has connected the University of Utah to its new downtown Salt Lake City data center and to UEN member organizations. This enables the university to meet the advanced connectivity requirements of both research and general data traffic of the university. In addition, extensions of the network to Provo and Logan are underway, enabling the network to serve Brigham Young University and Utah State University. 

UEN is an affiliate member of the U.S. Unified Community Anchor Network (U.S. UCAN) project connecting more than 65,000 member organizations to deliver  life-changing applications to communities via Ciena’s optical transport solutions.

The broadband connectivity was funded through the Broadband Technology Opportunity Program with an infrastructure grant made possible by ARRA. Other BTOP funded recipients using Ciena’s solutions to power future broadband activities in the U.S., includes CapeNet, Dakota Carrier Network, DC-CAN, Navajo Tribal Utility Authority, and MaineREN.

An example of future broadband activities, DC-CAN serving the District of Columbia is planning to deploy a high-speed middle mile broadband infrastructure to provide direct internet connections for community anchor institutions located primarily in economically distressed areas.

 For more information, go to www.ciena.com.

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Harnessing Wireless Innovations

The House Energy and Commerce’s Subcommittee on Commerce and Technology, Health, Oversight and Investigations held three days of hearings titled “Health Information Technology: Harnessing Wireless Innovation”. Potential regulations and taxes on smartphones, tablets, mobile apps, and federal regulations were discussed. In the three days, a number of witnesses expressed their viewpoints.

Robert Jarrin, Senior Director Government Affairs for Qualcomm Incorporated explained that on July 2011, the FDA issued a Draft Guidance on Mobile Medical Applications (MMA). Officials from FDA said that the final MMA guidance document would be de-regulatory. It is now March 2013, and the FDA has yet to release a final MMA guidance document. This has led to confusion, apprehension, and in some cases, reluctance by mobile health app developers to enter the market for fear of regulation

Representing the Newborn Coalition, Jim Bialick the Executive Director, told the Committee that medical apps are not medical devices so it was a surprise when the FDA issued their draft guidance to regulate mHealth apps as medical devices.

Benjamin M. Chodor, CEO, Happtique Inc., explained that unlike other aspects of the healthcare marketplace there is little to no barrier to entry into the health app market which means that basically anyone with an idea and programming skills can build a mobile health app but many are unaware of the regulatory landscape. What is needed is a balanced, risk-based approach to regulations.

Representing the mHealth Regulatory Coalition, Bradley Merril Thompson, General Counsel agreed that over regulating apps will negatively impact manufacturers and developers who have to comply with requirements that are disproportionate to the very low risk level of these products.

According to, Joseph M. Smith, MD, PhD, Chief Medical and Science Officer at West Health Institute, suggested “What is needed are streamlined, predictable, transparent, risk-based regulations, development of proactive regulations and reimbursement based on true functional interoperability, and development of a reimbursement policy that would align stakeholder’s incentives to drive the adoption of appropriate technology.”

After the multi-day hearing highlighted a great deal of uncertainty related to medical device taxes and regulations, FDA’s Christy Foreman, Director of the Office of Device Evaluation in the Center for Devices and Radiological Health (CDRH), informed the Committee members that FDA’s policy on mobile medical apps will not include the regulation of consumer’s smartphones or tablets.

She continued to say, “FDA is consulting with ONC and FCC and plans to prepare a report by January 2014 with a proposed strategy and recommendations for an appropriate risk-based regulatory framework for health IT that will include mobile medical apps.

Go to http://energycommerce.house.gov/hearing/health-information-technologies-harnessing-wireless-innovation for more information.

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Collaboration to Share Info

Today, life sciences organizations are managing in an environment with new responsibilities, questions, and critical choices. To deal with these issues, the Premier Healthcare Alliance has just launched the Healthcare Innovators Collaborative to enable the sharing of knowledge from health systems that are implementing ACOs. Premier’s research on care coordination, new payment models, resource utilization, and more will be available.

Several organizations have already joined the collaborative including ARUP Laboratories Inc., Baxter, Bayer HealthCare Pharmaceuticals, Inc., Eli Lilly, Integrated Healing Technologies LLC, Johnson & Johnson Health Care Systems Inc., and Ethicon Inc. Charter level enrollment is limited and is currently open for 14 more organizations to join by March 31, 2013.

The group will be provided the latest news on healthcare reform topics, issues, and legislation. Charter members will have access to insights gained through Premier’s PACT™, QUEST® and Bundled Payment Hospital and Health System Performance improvement collaboratives.

Detailed data will be provided on:

  • Care delivery and integration changes
  • New payment models
  • Utilization
  • Engagement and cost measurements
  • Patient-centered medical homes
  • Drug and device management
  • Data warehousing
  • High-value care networks

 

The Collaborative is led by a panel of experts including representatives from the Institute for Healthcare Improvement and the Mark Dixon Group LLC as well as Premier’s executive leadership.

This type of collaboration and innovation can help aid the sharing of best practices to identify better ways to support health systems and the communities they serve,” said Wes Champion, Senior VP of Premier Performance Partners.

To join the current charter members, email scott_pope@premierinc.com or call Alven Weil at (704) 816-5797.

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Funding New Companies

 PatientStream, a new company that developed an innovative electronic patient tracking system for hospitals, has received $500,000 in funding from the W Fund and partners. The W Fund is a $20 million private venture fund focusing on earliest-stage investments in technology-based start-up companies doing research in the State of Washington.

The system is being used in more than 50 departments across UW’s Medical Center, Harborview Medical Center, Seattle Cancer Care Alliance, and Northwest Hospital. In an outpatient department at Harborview Medical Center, patient satisfaction improved by 25 percent after implementing PatientStream which actively monitors patient wait times, so that when a patient waits too long, an alert is sent to a team member who will expedite the patient’s visit.

CEO Ben Andersen developed the technology with Peter Ghavami at UWs Harborview Medical Center and co-founded PatientStream with COO Keith Strekenbach. “We have improved our efficiency of operations by 90 percent which means that surgeries now start on time 80 percent of the time,” said Don Millbauer, Director of Perioperative Services at Harborview Medical Center.

Clearside Biomedical Inc., an Atlanta based ophthalmic pharmaceutical start-up company launched from research at Emory University and Georgia Tech, recently received $7.9 million in funding to continue drug and technology development for the treatment of ocular diseases. The new funding is in addition to a $4 million venture capital investment received by Clearside Biomedical in early 2012 that served as the foundation for the start-up company. 

Santen Pharmaceuticals Co., Ltd in Osaka, Japan will fund Clearside’s technology development and has entered into a research collaboration agreement for posterior ocular diseases. Santen along with new investor Mountain Group Capital and affiliates joins current investors Hatteras Venture Partners in Durham, the Georgia Research Alliance Venture Fund, and the University of North Carolina’s Kenan Flagler Business School Private Equity Fund. 

Clearside is developing microinjection technology that uses hollow microneedles to precisely deliver drugs to a targeted area at the back of the eye. If the technique proves successful in clinical trials and wins regulatory approval, it could provide an improved method for treating diseases including age-related macular degeneration and glaucoma, as well as other ocular conditions related to diabetes.

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Addressing Care Coordination

Bill (SB 1068) on care coordination for chronic diseases was introduced in the State of Connecticut by the Public Health Committee during the General Assembly’s January 2013 session. The bill calls for the Commissioner of Public Health to consult with the Comptroller and representatives of hospitals, healthcare facilities, along with local and regional health departments to develop a plan to meet the needs of the chronically ill.

The goal is to reduce the incidence of chronic diseases, improve chronic care coordination, and reduce the incidence and effects of chronic disease in healthcare facilities. The bill proposes that each year by January 15th, a report must be submitted to the General Assembly and then to the Joint Committee on Public Health. The annual report would be posted on the Department of Public Health’s web site within 30 days.

Each report would need to include information on but not be limited to:

  • A description of the chronic diseases that are most likely to cause a person’s death or disability
  • The approximate number of persons affected by chronic diseases and an assessment of the financial effects of each disease on the state, hospitals, and healthcare facilities
  • A description and assessment of programs and actions that have been implemented by the department, hospitals, and healthcare facilities to improve chronic care coordination
  • The source and amounts of funding received by the department to treat persons with multiple chronic conditions that are the most prevalent in the state
  • A description of the chronic care coordination that exists between the Department of Public Health, hospitals, and healthcare facilities
  • Detailed recommendations on actions that need to be taken by hospitals and healthcare facilities and recommendations to reduce hospital readmission rates, and how to achieve effective drug therapy monitoring
  • Identify future goals for coordinating care and reduce the incidence of persons having multiple chronic conditions

 

The legislation was referred to the Joint Committee on Public Health and a public hearing is expected to be held in March.  

 

 

 

 

 

 

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Grants for Rare Disease Research

Representative Barbara Lee form California introduced the bill “Neuromyelitis Optica (NMO) Consortium Act” (H.R. 660) to provide grants to do research on the causes, risk factors, and biomarkers associated with NMO. So far, there has not been a comprehensive study that analyzes all the relevant clinical, biological, and epidemiological aspects of NMO that can be used to identify potential risk factors and biomarkers for NMO

NMO an uncommon disease syndrome can attack the central nervous system This devastating neurologic disease can lead to blindness and paralysis and it is estimated there are 11,000 patients with NMO in the U.S. Women are affected 7 to 9 times more than men and a large proportion of NMO patients are African-American.

NMO is a central nervous system disorder causing primarily swelling and inflammation of the eye nerves and the spinal cord. NMO occurs when the body’s immune system reacts against its own cells in the central nervous system that occurs mainly in the optic nerves and spinal cord, but sometimes in the brain

NMO was once thought of as a variant of MS and is still sometimes misdiagnosed as MS. Yet it differs from MS, since NMO does not often involve the brain, severe attacks are more robust as compared to MS, and the pathophysiology differs from MS.

According to NIH’s National Institute of Neurological Disorders and Stroke (NINDS), there is no cure for NMO, but there are therapies to treat an attack while it is happening to reduce symptoms and to prevent relapses. Doctors usually treat an initial attack of NMO with a combination of a corticosteroid drug to stop the attack and an immunosuppressive drug to prevent subsequent attacks.

Representative Lee’s bill would enable the Director of NIH in collaboration with the Director of the National Institute on Minority Health and Health Disparities to coordinate the efforts to establish a National Neuromyelitis Optica Consortium.

The legislation would enable the Consortium to provide grants for not fewer than five years so that the Consortium would be able to conduct research on a minimum of 25 individuals diagnosed with NMO.

The Consortium would be responsible to design a common study, develop standard protocols, methods, procedures, and assays to use with individuals enrolled as study participants, develop specific analytical methods for examining data, and provide provisions to review enrolled cases. Another objective would be to designate a central laboratory to collect, analyze, and aggregate data with respect to the research and then make this data and analysis available to researchers.

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