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Ethical Need for Better Health Care Regulatory Oversight

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Newswise Patients in health care systems are suffering for a lack of clear federal regulatory guidance in support of low-risk quality improvement research, according to a viewpoint article by health and policy experts in the Journal of the American Medical Association (JAMA).

The Office for Human Research Protections, the Office for Civil Rights, and the US Food and Drug Administration should provide more complete and coordinated advice, to avoid institutions making unnecessarily restrictive decisions on what research can go forward because of uncertainty about what regulations allow, thus impeding much-needed medical research, the article says, under the heading Time for a Change.

Looking specifically at the generally low- or no-risk type of research known as comparative effectiveness research, the viewpoint asks: what level of oversight is necessary? The authors offer recommendations for both the current health policy landscape and a hopeful vision of harmonized regulation in transparent, data-driven health care systems of the future.

Our federal regulatory system is critical in protecting patients when research poses risks or threats to their wellbeing. But our regulations also need to have flexibility to allow different oversight options for research that alters patients care very little yet has the opportunity to improve care enormously, says Nancy Kass, co-author of the viewpoint and the Deputy Director for Public Health at the Johns Hopkins Berman Institute of Bioethics.

All clinical care carries risk, and to assume that research automatically imposes additional risks beyond those the same patient would otherwise have experienced in clinical care may overinflate the risks of research and underestimate the risk of not conducting these evaluations, the viewpoint states.

Joining Kass in the opinion is Richard Platt, a research physician trained in infectious diseases, of Harvard Medical School and Pilgrim Health Care Institute, and Deven McGraw, a health care lawyer and privacy expert, of the Center for Democracy and Technology.

The authors highlight the paradox of stringent research regulations for studies evaluating changes in how healthcare is organized coexisting alongside the lack of oversight when administrative decisions are made to health system operations. Such administrative clinical decisions are not considered research and thus are not subject to review, patient consultation or other transparency yet can have considerable impact on patients experience and successful treatment. The authors use the example of changing the ratio of nurses to patients, which could have profound effects on patient outcomes.

The viewpoint also stresses the importance of patient engagement in oversight and in the research process. The engagement of patients and other stakeholders will be critical to collecting and using data in ways that seem respectful and acceptable to patients.

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Ethical Need for Better Health Care Regulatory Oversight

North Dakota health care worker shortage widespread

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GRAND FORKS A shortage of health care workers including doctors, specialists, nurses and other professionals is a major concern in three-fourths of the 36 North Dakota communities surveyed in health needs assessments conducted over the past three years.

Other top priorities include mental health issues, including substance abuse, as well as health care costs, obesity and financial viability of hospitals, according to a new report from the Center for Rural Health at UNDs School of Medicine and Health Sciences.

Theres a workforce shortage statewide, said Karin Becker who, along with Ken Hall, conducted assessments in 21 of the states 36 communities with critical access hospitals. The report also included results of a half-dozen surveys conducted by hospitals or other organizations.

The Community Health Needs Assessments are required every three years for nonprofit hospitals as part of the federal Patient Protection and Affordable Care Act. The first report covered 2011 through 2013.

As a whole, the identified needs paint the current picture of health needs confronting rural communities and affecting the state, Becker summarized in the report. They provide a baseline for which to measure change in the future and a way to chart progress.

The CHNA process involves a combination of surveys and community focus groups to identify communities most pressing health needs, according to Becker. The assessments involve several steps, including interviews with health care workers and community members.

Once tentative results are compiled, Center for Rural Health staff members then meet with community members, who vote on which items are the highest priorities.

Its a way for a community to articulate their needs. Then, depending on how they prioritize their needs, we choose a top five, she said.

Top needs

Other top community health issues that emerged from the process were aging population services, alcohol/substance abuse, and maintaining emergency medical services, according to the report.

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North Dakota health care worker shortage widespread

Health care sign-ups hit 5M mark

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AP Photo/J. Scott Applewhite, File

This Oct. 30, 2013, file photo shows Health and Human Services Secretary Kathleen Sebelius testifying on Capitol Hill in Washington. The administration says more than 900,000 people enrolled for coverage under President Barack Obamas health care law in February. But its starting to look like the White House could miss its unofficial goal of signing up 6 million people by the end of open enrollment season March 31.

Posted: Monday, March 17, 2014 5:54 pm | Updated: 5:56 pm, Mon Mar 17, 2014.

Health care sign-ups hit 5M mark Associated Press |

The Obama administration says more than 5 million people have signed up for private health insurance under the new health care law.

That still leaves about 1 million to go over the next two weeks for the White House to meet its latest goal of 6 million enrolled by March 31.

That would work out to more than 70,000 people a day. And some independent analysts say that's a stretch.

Medicare administrator Marilyn Tavenner announced the 5-million milestone in a blog post Monday.

March 31 is the last day to enroll for a taxpayer-subsidized health plan through the new online markets, or exchanges.

It's still unclear whether the White House will grant an additional grace period for people who've started but not finished their applications by that date.

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Health care sign-ups hit 5M mark

InfoSight Inc. Signs Marketing Agreement with Unified Physicians Management (UPM): Providing Health Care Centers with …

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Miami Lakes, FL (PRWEB) March 18, 2014

InfoSight Inc., provider of Managed Health Care IT Security, HIPAA Compliance and Vulnerability Management services for regulated industries, announced a new agreement with Unified Physicians Management (UPM). UPM is the management services organization to Floridas largest Obstetrics and Gynecology group practice, Florida Woman Care and to Unified Womens Health Care in Georgia and North Carolina. UPM offers comprehensive practice management to its clients, including technology solutions, electronic health records, human resource management, accounting, managed care contracting and management, group purchasing and data analytics.

The agreement offers information technology (IT) and IT security support and HIPAA Compliance services to UPMs Care Centers throughout Florida, Georgia and North Carolina. Services include Network Support, Managed IT Security Services, HIPAA-HITECH Risk Assessments and GAP Analysis, among others.

InfoSight has served regulated industries nationwide minimizing risk exposure for more than 15 years, providing the highest levels of IT security assurance and regulatory compliance. InfoSight provides straightforward, highly-robust, affordable solutions. Offering a broad portfolio of IT security and HIPAA compliance solutions designed to solve information technology challenges unique to the health care industry, InfoSight identifies, measures, controls and monitors technology to avoid the risks that threaten the security and soundness of medical practices.

We feel the value added services that will be offered to our Health Care Centers will complement our existing suite of services, said Allan Boshell, Chief Operating Officer of UPM. This comprehensive approach will reduce IT support costs, as well as strengthen the HIPAA compliance posture and IT security of Unified Physicians Management client physicians.

By proactively addressing patient privacy and information security from a technology perspective, medical practices can reduce their risk foot print, said Tom Garcia, CEO of InfoSight. By partnering with InfoSight for their IT and information security needs, UPM Care Center Practice Managers and health care providers can focus on core medical practice competencies, improving operational efficiencies and reducing overall IT and security costs.

To learn more about special discount pricing on IT security support and HIPAA Compliance services contact InfoSight Inc, or find them in UPMs most recent Group Purchasing Directory (GPD) booklet.

About InfoSight Inc. InfoSight Inc. offers proven and affordable HIPAA Compliance and IT Security and Vulnerability services that protect and optimize how a health care organizations critical information is processed, managed and stored. For more than 15 years, InfoSight has served regulated industries like health care nationwide minimizing risk exposure and providing the highest levels of security assurance and regulatory compliance. InfoSights offering fits any budget with minimal upfront cost or capital outlay and can be installed in-house or as a complete Managed Services offering. For more information about HIPAA compliance, visit http://www.infosightinc.com or contact us at 305-828-1003 / 877-577-9703.

About Unified Physician Management (UPM) UPM is the management services organization to Floridas largest OB/Gyn group practice, Florida Woman Care and to Unified Womens Health Care in Georgia and North Carolina. With over 500 physicians since its inception in 2009, UPM gives physicians the ability to concentrate on their medical practices growth, the pursuit of quality initiatives, and income growth while improving patient satisfaction. Unified Physicians Management offers comprehensive practice management to its clients, including technology solutions and electronic health records, human resource management, accounting, managed care contracting and management, group purchasing, and data analytics for quality initiatives. http://www.unifiedhc.com

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InfoSight Inc. Signs Marketing Agreement with Unified Physicians Management (UPM): Providing Health Care Centers with ...

Health care reform enters phase 2 – Sun, 16 Mar 2014 PST

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Now that Americans by the hundreds of thousands are signing up for health insurance coverage, reformers are movingon.

They want high health care prices to be disclosed and drivendownward.

They want the most effective care providers identified for thepublic.

They want a medical extension service to get best-practice ideas out to busy providers in stressed ruralareas.

They want mental health care to be better coordinated with primary medical care, so communities no longer have to use jails as mentalhospitals.

Last week, as Washingtons Legislature wrangled its way to adjournment, Gov. Jay Inslee and other

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Now that Americans by the hundreds of thousands are signing up for health insurance coverage, reformers are movingon.

They want high health care prices to be disclosed and drivendownward.

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Health care reform enters phase 2 - Sun, 16 Mar 2014 PST

Newtown is struggling to meet demand for mental health care

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Some of the charities paying for mental health care for children and families affected by the Sandy Hook massacre are running short of money and officials don't know how much they'll need and for how long to repair the psychological scars from the mass shooting.

Newtown officials are applying for a federal grant and charities are pooling their resources in an attempt to ensure that free long-term mental health care remains available following the December 2012 shooting that left 20 first graders and six educators dead.

We hear in the media, 'Well Sandy Hook was 14 months ago, isn't everything fine?' said Candice Bohr, executive director of the Newtown Youth and Family Services. Well, no it's not and we get calls every day from the school wanting to address an issue. I would love to say that in 10 years we're going to see a huge drop and everyone's better and we've moved on, but that's not the case.

Three of the charities that have been providing funds for services have started working together, while the charity that has raised the most money the Newtown-Sandy Hook Community Foundation says that it will likely join the alliance soon.

The Newtown Lions Club, which raised $350,000 for mental-health services in the wake of the shooting, has told the 250 people it served that it could no longer directly pay their mental health bills because fundraising was being outpaced by demand.

Other charities are picking up the slack. The town's Rotary Club and the Newtown Memorial Fund, which had been spending a combined $30,000 a month on mental health care for 150 families, partnered with the Lions Club, said Brian Mauriello, founder of the Newtown Memorial Fund.

Those who need help are being steered to the state's Office of Victim Services, which processes applications for money from a pool created by all three charities.

So far, nobody has been turned down.

I don't think anybody has a crystal ball to say whether there's going to be enough money or not, said Linda Cimino, the director of the state Office of Victim's Services I do know that the plan is for a 15-year horizon.

The Newtown-Sandy Hook Community Foundation has about $4 million left after giving more than $7 million to the 40 families most affected by the shooting.

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Newtown is struggling to meet demand for mental health care


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