Forward brings its personalized healthcare service to Los Angeles

Forward, the San Francisco-based startup that’s looking to refashion healthcare services in Apple’s image, is expanding with its first location in Los Angeles.

Weaving together a number of Silicon Valley’s favorite healthcare trends, the company’s services combine proprietary, purpose-built medical devices with algorithmically enabled diagnostic tools, and the latest in gene, bacteria and blood tests to provide a holistic view of its patients’ health.

These technologies and services include: unlimited access to its medical staff; baseline screening; blood and genetic testing; wellness and nutrition counseling; and ongoing monitoring from wearable sensors provided at the clinic. Support and access to its AI and 24/7 access to medical staff through the app are available exclusively to anyone who’s willing to pay the $149 per month fee.

At its launch, Adrian Aoun told us about 15 percent of its early users come from underserved communities and had received free membership. Members also get their first month of prescription medicine free through Forward’s onsite pharmacy, which also offers vitamins and supplements.

Forward also plans to offer vitamins and other supplements and wearables through the onsite store, and Aoun said he would like to offer other alternatives, such as acupuncture, in the future.

Opening in a small office on the first floor of the Westfield Century City mall, Forward’s Los Angeles office will contain all of the bells and whistles that brought it so much attention when it opened its first San Francisco location in January.

There are custom-built exam rooms kitted up with interactive, touch-screen displays — part of what the company touts as an integrated, paperless system for new electronic health records.

The centerpiece of the company’s facility is a purpose-built body scanner that collects basic vital signs like temperature, pulse and arterial health, which are then sent to the company’s staff doctors.

Those aren’t the only diagnostic tools. The company also has an app and is rolling out services around fertility and sleep tracking, as well as dermatological and optometry services in its two offices.

 

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Rural health care centers provide low-cost care

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Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

To get dental services she can afford, 73-year-old Juanita Jenkins has one of her sons drive her 16 miles from her home in the Duval neighborhood in northeast Gainesville to the Alachua County Organization for Rural Needs (ACORN) Clinic in Brooker. The 32-mile round trip is worth it, she says.

Jenkins is one of thousands of people in Alachua County and surrounding counties who need the inexpensive services provided by nonprofit organizations, such as ACORN, which was established in 1974 to serve area migrant workers.

“I started coming here last year and I’ve been here to the dentist about four or five times,” said Jenkins, after getting fitted for dentures. “They take good care of you here, and I would recommend their services to anybody.”

Thursday is National Rural Health Day, created to recognize rural health workers for their efforts and their collaborations that address the unique challenges faced in rural communities.

Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

ACORN has grown from a singlewide trailer on a sandy lot of land to several modular buildings that house dental, medical and administrative offices at 23320 N. State Road 235 in Brooker.

The clinic provides a range of medical, dental and mental health care services, referrals to other health services and social services and professional education and training, King said.

Like ACORN, Archer Family Healthcare, an arm of the University of Florida College of Nursing, started out in a small building before moving into a larger building to better serve its patients. According to Joan Newell-Walker, manager of the clinic, retired Dr. Dee Williams lobbied to establish the clinic after being urged to do so by Archer residents. Williams’ efforts led to the clinic opening in 2001, and it has grown from an approximately 1,000-square-foot, two-story bungalow to a more than 5,000-square-foot facility composed of six modular buildings that were built in downtown Archer in 2007.

“We have grown to accommodate approximately 5,000 patient visits annually,” Newell-Walker said.

Patients visit the Archer clinic for a variety of reasons, including chronic diseases like diabetes, hypertension, chronic obstructive pulmonary disease, as well as prenatal care, medication consultations, health education and disease prevention, immunizations, physical exams and more, Newell-Walker said.

The clinic in Archer was established to meet the needs of residents who live in the rural community in southwest Alachua County who didn’t have a health care facility before the clinic opened. But it’s grown to serve patients from throughout North Central Florida, Newell-Walker said.

The clinic’s funding comes from local, state and federal sources, and it’s run by advanced registered nurse practitioners, Newell-Walker said.

The nurse practitioners provide expert care for patients and are supported by other health care professionals, including a case manager, community health nurses and a consulting physician, Newell-Walker said.

At ACORN, a wide variety of dental, medical and mental health care services are provided, including disease management education, general medical care, reduced cost X-rays, women’s health care, dental exams and X-rays, extractions, orthodontics, root canals and more.

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Innovation in education looks to cure doctor shortage

Business News | 20 hours ago |

Arizona has a serious doctor shortage. The state is a “Designated Health Professional Shortage Area” and according to the latest numbers from the Health Resources & Services Administration, the department that makes these designations, slightly less than half of Arizona’s primary care health professional needs are met.

Video by Jesse A. Millard

Since only 49 percent of the state’s needs are met, Arizona residents, particularly those in the rural parts of the state, are subject to long wait times for regular checkups because of the doctor shortage.

Arizona needs to add 520 physicians in order to lose its “shortage” designation. These doctors won’t appear out of thin air, but Arizona does have a great pool to reel new doctors from — its growing medical schools.

Midwestern University’s Arizona campus in Glendale sees an estimated 40 percent of its graduates residing and practicing in Arizona, says Dr. Kathleen H. Goeppinger, president and CEO of Midwestern University.

The University of Arizona College of Medicine in Phoenix offers a pipeline to local communities. The efforts include Saturday Scrubs and Summer Scrubs, where those interested in the medical field are welcomed into simulation labs to watch students care for mannequins — or faux patients. The hope is the program will spark the interest in those considering a career in the medical field.

And Mayo Clinic welcomed its first class of about 50 students to the Valley this year, making Arizona the third state to receive a Mayo Medical school, behind Minnesota and Florida.

The Mayo Clinic School of Medicine has created a curriculum that is designed to not only teach students how to do certain medical procedures, but also teach them the ins and outs of the healthcare delivery system.

“We want to prepare physicians to meet the needs and challenges of the healthcare system,” says Michele Halyard, MD, dean of the Mayo Clinic School of Medicine’s Arizona campus. “We are hoping that many of the students will wind up staying in Arizona for their residency and ultimately becoming a physician within the Arizona community.”

Class act

In late September, several medical groups in the state formed an alliance that will work to increase the number of doctors and healthcare professionals in Arizona and ease the doctor shortage.

Maricopa Integrated Health System, Creighton University School of Medicine, Dignity Health’s St. Joseph’s Hospital and Medical Center and District Medical Group will work together as the Creighton University Arizona Health Education Alliance to expand Arizona’s offerings of healthcare education programs.

“With this alliance, we have the opportunity to continue to strengthen Arizona’s reputation as the home of some of the best medicine in the nation,” says Patty White, president and CEO of St. Joseph’s. “The affiliation will enable us to increase the numbers of doctors and other healthcare professionals who will want to make Arizona their home.”

Arizona is also on the cutting edge of medical education, training and creating doctors who will be prepared to deliver care in a modern healthcare setting.

This is being done through various medical simulation centers in the state. Simulation is still fairly new in medical training and preparation. However, many medical schools across Arizona are adopting this new practice in hopes of producing better trained physicians.

Simulation centers vary from facility to facility, but they typically involve mannequins that enable students, practitioners and residents to learn how to deal with many different aspects of medical care and treatment.

Innovation abounds

The Banner Simulation Medical Center’s 55,000-square-foot simulation center is one of the largest simulation centers in Arizona, where trainees can fully experience a hospital-like atmosphere.

The center is nestled in a decommissioned, hospital where students can immerse themselves in simulations at an intensive care unit, surgery center, operating rooms and training labs. Students learn how to take blood samples, utilize proper sanitary measures and more, says Karen Josey, senior director of simulation at Banner Health.

“Simulation is all about patient safety,” Josey says. “Simulation goes from simple training such as putting in an IV, to the more complex tasks and scenarios, such as a chest tube insertion.”

The center also offers a day in the life of a nurse, where students are assigned a number of patients that they must watch, prioritize and care for throughout the day. This is followed by hours of debriefing on what needs to be improved and what was done correctly.

The University of Arizona currently has two simulation labs. One located in Tucson — which will open in May of 2018 — and one in Phoenix.

The Phoenix simulation center consists of three wings, 14 hospital rooms, two surgical stations, nine debriefing rooms, six onsite training rooms, three scrub sinks, ultrasound machines, 3-D models of the brain and eyes and a virtual reality simulation.

All of this is in hopes of accomplishing the UA’s “mission of providing the best training to students, residents and fellows, but it also helps recruit and expand our pipeline of students who might consider entering careers in medical fields,” says Guy Reed, dean of the University of Arizona College of Medicine – Phoenix.

Midwestern University is also home to a simulation lab. Its lab is made up of 19 exam rooms and extends to seven veterinary-based exam rooms. Also, there’s an ICU, emergency/trauma room, a pediatric floor, maternal fetal simulator, operating rooms and more.

Arizona is filled with simulation labs, including two more with Mayo Clinic. Mayo’s facility contains about six fully equipped exam rooms that are identical to those in the Mayo Clinic Cancer Center, and another simulation center within its hospital.

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Health Education England launches online workshop on improving digital readiness

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Health Education England is launching an online workshop to gather views on digital readiness.

The organisation is working in collaboration with Digital Health and innovation and crowdsourcing agency Clever Together on the online workshop, which forms part of the Building a Digital Ready Workforce programme.

It will be launched on 22 November in partnership with BCS Health and Care, the Federation of Informatics Professionals in Health and Social Care, and the Faculty of Clinical Informatics.

James Freed, chief information officer at Health Education England, told Digital Health the exercise was a chance to gather the views of those who already have a strong voice as well as those who are less commonly heard.

“In almost all technological programmes I have seen, our efforts are mostly about technology and very little about process, and the process redesign, and almost none on people,” he explained. He hopes the new online workshop will address that.

Andy Kinnear, chair of BCS Health and Care, added the aim was to hear from “digital experts; the wider group of people involved in the digital space such as nurses, doctors and care professionals; and the entire health and social care workforce”.

The online workshop will run for about three weeks and its results will form the basis for how the BRDW programme will prioritise and invest £6m over the next four years. Its findings will be extensively covered by Digital Health.

You can register now for the online workshop. Our feature article gives more detail – including interviews with James Freed and Andy Kinnear. Keep an eye on Digital Health over the next few weeks for ongoing coverage.

Women’s Forum panel addresses women’s health, education challenges

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Health and education challenges that women face were the center of a panel discussion which took place Monday morning as part of the Women’s Global Leadership Forum.

Courtesy Women’s Global Leadership Forum

 

A panel addressing health and education challenges facing women took place Monday morning as part of the Women’s Global Leadership Forum. The discussion was facilitated by Rebecca Dillingham, director of the University’s Center for Global Health, and was comprised of of women who gave their global perspectives on the issues.

Newcomb Ballroom was packed with an audience that included high schoolers, University students, alumni and faculty members.

Vivian Pinn, the first full-time director of the Office of Research on Women’s Health at the National Institutes of Health, spoke briefly about being the first African-American female graduate from the University Medical School.

“I went into that first morning class in the fall of 1963 thinking that when I looked around the room and saw only white men — that the other women and people of color must just be late getting there,” Pinn said. “Then I realized that I was it. It was me and my classmates.”

Pinn said one of her main priorities she has pursued throughout her life is trying to ensure the medical world listens to women and discusses women’s health.

“I have focused on things that have been important to me my whole life,” Pinn said. “That is — What about the health of girls and women? What about girls getting careers in medicine? I couldn’t think of a better time to focus my energy on women’s health.”

The panel centralized their conversation on the importance of enabling education at a young level to facilitate greater gender equality amongst leadership roles.

Maya Ajmera, president and CEO of the Society for Science and the Public, spoke about her trip to India in which she saw train platform schools. The trip inspired her Global Fund for Children which works on behalf of vulnerable children. Ajmera said in the future she wants to focus on empowering local, grassroots organizations to enact change.

“Grassroot entrepreneurs …  They are the ones that resources really need to get put into because I think they’ve been starved,” Ajmera said. “I think they’ve been starved in this country, but I also see that starvation globally. So if we’re going to reach people, it’s through the grassroots.”

Ajmera also said one of her main priorities is to ensure that girls continue their education beyond primary school.

“We have to get the education of girls at the secondary level globally up,” Ajmera said. “The development goals of the U.N. have achieved great success in getting primary school admissions very high. But secondary school really has to be an emphasis.”

Abinet Sitotaw, a gender and nutrition advisor for nonprofit organization CARE-Ethiopia also said education was important in promoting women and girl’s empowerment. Speaking of her own personal mission and the Mandela Washington Fellowship, Sitotaw said her priorities involved getting girls into safe educational institutions.

“It’s going to be a leadership academy whereby I manage to bring a group of young girls who cannot attend secondary schools to the city,” Sitotaw said. “I want to give them a boarding school whereby they can get a state of the art education and also leadership skills.”

 

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The ISO 13485: 2016

The ISO 134855

The ISO 13485, which is the ISO’s global medical device standard; was upgraded significantly in 2016. This upgrade was carried out primarily to help the standard keep up with the changes that have taken place in the industry in about the decade and a half since the previous standard was brought into effect in 2003. Changes have taken place in a number of key areas of the medical device field, but the most important changes relate to the changes in technology and in relation to the increased importance of risk management at almost all levels in the medical device industry.

The earlier version was based on the ISO 9001:2000 standard, while the new upgrade is based on a later standard, the ISO 9001: 2008. Changes have been carried out into almost all the sections of the new standard, with the most important areas that have been changed including flexibility, the requirements from medical device companies to adhere to regulatory requirements, the inclusion of the risk based approach into the organization’s QMS, medical device filing and documentation, verification and validation, design and development, training, supplier monitoring and so on.

QMS is an important area of change

The ISO 134851

The QMS is the most prominent area in which the new document differs from that of the earlier version. Although the new version is considerably more closely aligned to the FDA’s Quality System Regulations (QSR); there still exist major differences. Not getting a proper grasp of these differences has the potential for creating problems in implementation.

Medical device companies also need to consider the Medical Device Single Audit Program (MDSAP), the mechanism through which the regulatory systems in a few jurisdictions will continue to rely on ISO 13485:2016. In relation to this mechanism, the fundamental difference between the US and the EU is this: the US will participate in MDSAP, but doesn’t expect to change its regulations, while the EU is not going to participate. It has published its own version, EN ISO 13485:2016, and will continue with the existing Notified Body system. however, the EU will promulgate in its own set of new regulations that will replace the directives. These will lead to new regulations, which will be new versions of EN ISO 13485:2016 and EN ISO 14971:2012.

It is crucial for medical device companies to keep track of the changes introduced in ISO 13485:2016, as this is the new standard that they have to comply with. While it is not legally binding to do this; they gain in a number of ways in being compliant with these changes.

Proper and full learning of the ISO 13485:2016

The ISO 134852

Being compliant with the new version requires a clear understanding of the new regulation, the ways in which it has to be implemented, the areas of work that need to be changed, and so on. A seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will explain all these.

At this seminar, the Director is Dan O’Leary, who is the President of Ombu Enterprises, LLC. Dan, who brings more than 30 years’ experience in Quality, Operations and Program Management in regulated industries including aviation, defense, medical devices, and clinical labs, will offer a complete understanding of how the new regulation needs to be implemented.

Please log on to The ISO 13485: 2016 to enroll for this seminar and get the right perspective of how to implement ISO 13485:2016. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Implementation needs to be done quickly

The ISO 13485

The final version of the new ISO 13485:2016 standard is now available for companies to start implementing. The areas into which changes have to be carried out are quite expansive and huge in number. For many companies, the timeframe for implementation is quite short, depending on the expiry date of their current certificate. Dan will help participants overcome this handicap, and will offer practical implementation advice and suggestions to participants.

He will also use exercises and examples to help participants understand the ways of implementing according to the new guidelines and also analyze the implications of the newly revised regulation, in particular, regulatory systems including MDASP and its nonconformity grading system. This seminar will have the following agenda:

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Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward

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This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory frameworks for food and drugs to support innovation to benefit society, while guaranteeing safety and efficacy of products and ensuring the science base.

Introduction

The combined genomes of the microbial ecosystems that live in symbiosis or as commensals with the human body can be defined as the human microbiome. These microbial ecosystems not only include bacteria and archaea, but also fungi, protozoa, and viruses. Different microbial ecosystems colonise the mouth, the skin, the vaginal and intestinal tract, of which the latter has the highest biodiversity, composed of more than 1000 phylospecies.

An Interface Between Human Genetics and Diet: the Gut Microbiome

The human gut microbiota has been described as a key biological interface between human genetics and environmental conditions, such as diet, that can modify the composition and the functioning of the intestinal microbiome. In that sense, it may be considered a virtual organ which is an integral and essential part of the body.1 Through nutritional intervention, the gut microbiome may be altered to generate better wellbeing and protection against many diseases or even to cure certain conditions.2-4

The gut microbiome can be linked to many Non-Communicable Diseases (NCDs), such as cardiovascular diseases, cancer, diabetes, and metabolic syndrome related to increasing incidence of obesity. More recently, also neurological diseases have been related to gut microbiota and diet and are considered as NCDs.5, 6 The burden of ageing related dementia and other NCDs is exponentially increasing in relation to changing life styles and ageing of the population, conditions that are associated with gut microbiome alterations. Changing demographics worldwide, combined with the broader adoption of the western diet and lifestyle increases the burden of NCDs, creating serious challenges for the public healthcare systems. Prevention and more efficient treatment of NCDs not only offer important economic advantages for healthcare systems, it also contributes to the reduction of poverty as only healthy people can actively participate to society and economies.7-9 Recent scientific studies are linking dietary habits to an array of health conditions in new ways and indicate that nutrition has a determining influence that start even before birth and can influence the development of complex pathologies.10, 11

Opportunities and Hype

New insights about the importance of the intestinal microbiome and the modulating effect of diet are opening new possible ways of treatment and prevention that may contribute to the sustainability of healthcare systems by keeping the increasing healthcare costs under control. Innovations based on better understanding of how the intestinal microbiome functions and regulates our health and how it is impacted by what we eat are expected also to lead to preventative medicine and contributions to longer wellbeing in general.

However, the field is subject to some hype. Although insights are growing fast, at this moment it is still unclear how health or disease is determined by the human microbiomes. In most cases, a certain microbiome composition can at best be associated with certain condition. The causal relation of nutrition, gut microbiome composition and health is not clearly understood yet, such as whether a healthy microbiome can be defined at population level, what determines its resilience when disturbed, or how its composition can be beneficially manipulated. Such primary knowledge is required before therapies targeting the microbiome can be developed.

Nevertheless, there is a clear interest of food and pharmaceutical developers and industries to develop new products that target the gut microbiome, for better well-being or to manage chronic disease conditions. Moreover, microbiomes are also a source of novel bioactive compounds that may be used for innovative applications.

Identifying Policy Needs

To follow the pace of new scientific insights and translate these to innovative applications, there is a need to accelerate policy actions at the national and international level, to address scientific and regulatory challenges as well as to ensure safety and efficacy and efficient take up by consumers and healthcare professionals.12-14

To stimulate innovation based on the new insights of how the human microbiome and the gut microbiome in particular is functioning, in May 2016, the department of Economy, Science and Innovation of the Flemish Government in Belgium organized a workshop on ‘The Microbiome, Diet and Health: Assessing Gaps in Science and Innovation’ in Brussels in collaboration with OECD and the Business and Industry Advisory Committee (BIAC), the industry association linked to OECD.15

This workshop brought together scientists from academia and industry, experts in regulatory issues and policy makers to identify and discuss on policy needs for this field to progress and deliver upon the promises. The regulatory frameworks in place need to follow fast the new developments and combine a right balance between measures to ensure safety and consumer/patient protection and flexibility to adapt to these new developments.16-18

This article summarizes some of the policy needs that were identified as well as messages from workshop participants, how to address these and help move from hype to solid intervention or prevention. A complete workshop report is published by OECD.

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