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Private Access Wins Top Honor with 2009 TEPR+ Hot Product Award

February 5, 2009

“Private Access ... was awarded first place in the 2009 ‘Hot Product’ award category at the Annual TEPRplus™ (Towards the Electronic Patient Record) Conference. The award was made for the company’s go-to-market tool suite that transforms the multi-billion dollar clinical trials recruitment market, including the PrivacyLayer™, TrialsFinder™ and RecruitSource™ applications. Presented each year to innovative products that bring the most positive change to health care, the Hot Products awards are aggressively contested by TEPR exhibitors. Entries were rated on criteria including product value, functionality, infrastructure and integration, and differentiation. [...] Private Access’ technology addresses two key objectives of the Obama Administration: lowering health care costs by investing in electronic information technology systems, and safeguarding Americans’ right to privacy. Whereas privacy has been characterized by some as being an impediment to data liquidity, the Private Access technology is architected to be privacy-enabling, permitting each consumer to decide who can see his or her personal health information. Private Access was one of four finalists in the Hot Products award category, and among 700 Conference participants. Claudia Tessier, Medical Records Institute Vice President and organizer of the TEPR Awards stated, ‘Our goal in holding this yearly awards program is to recognize vendors’ investments in producing valuable health IT products and to help potential consumers make their selections. We congratulate the honorees on their outstanding products.’   Read More   |   Read other coverage

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Privacy Concerns Slowing Research

January 18, 2009

“We wouldn’t stand in the way of essential research [due to a heightened sense of privacy about the human body]. Or would we? It seems in fact that we do. The problem has to do with confidentiality. Most of us believe that when we see a doctor, what goes on in the treatment room is no one’s business but our own. We expect the record of our visit to remain private. [...] It might seem the answer is obvious. Simply ask patients for permission to scan their files. But seeking consent isn’t always practical. [...] Why not just strip the records of anything that would identify the patient, such as name, address or telephone number? [But] concerns about confidentiality have become so dominant, not even this solution works. Experts argue that even when the data is anonymous, it might still be manipulated to reveal personal details.[...] The result is that medical research is being paralyzed. [...] No one disputes that patient files must be handled in a confidential manner. It’s completely unacceptable, for example, to see medical records misplaced, or lost in transit, as happened recently in our province. And we must certainly place limits on the use of such material. While most Canadians support legitimate research, we oppose selling health data for commercial purposes. But it sounds like the pendulum has swung too far…. Like most policy dilemmas, there is a sensible middle ground here. So long as patient records are suitably anonymous, additional barriers are unnecessary. Privacy should be protected to the level any reasonable person would expect, while still allowing vital research to go forward.” Read more

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Group: HIPAA a Barrier to Research

June 16, 2008

The HIPAA privacy rule is having a negative impact on the advance of biomedical research and the search for treatments, according to a new report from The Association of Academic Health Centers (AAHC). The Washington-based group’s report describes several disruptive consequences of the rule, including confusion for patients, misinterpretation by research participants, barriers to patient recruitment, and burdensome administrative procedures that increase administrative costs. It also offers specific recommendations for how the HIPAA privacy rule should be revised [including] revision of HIPAA to help resolve current conflicts between state privacy acts and HIPAA regarding tissue banks and other genetic research.   Read more   |   Read report

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Going Wiki, 23andMe Using Web to Recruit Customers for Disease-Risk and ADR Trials

June 4, 2008

“Personal genetics company 23andMe launched a new online effort last week to recruit its customers to participate in studies trying to shed additional light on genetic predispositions for certain diseases and adverse drug reactions. The initiative [is] called 23andWe….  The first 23andWe project [will be a genome-wide association study] to try to discover the specific genes associated with Parkinson’s, as well as the environmental factors that contribute to its development.  [The study] will focus on Parkinson’s disease through a partnership with the Parkinson’s Institute of Sunnyvale in California. The project plans to use web-based communities to recruit patients for clinical research with the ultimate goal of increasing the quantity and quality of data collected. [...] As part of the study, participants will be enrolled through the Parkinson’s Institute and genotyped through 23andMe’s personal genome service. The Michael J. Fox Foundation will pay for the genotyping, according to 23andMe.” Read more (subscription required)   |   Read Press Release

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FDA Initiative Aims To Streamline, Modernize U.S. Clinical Trials System

June 2, 2008

“There is another problem dogging clinical trials: It’s hard for people to find out about them.  [According to some experts,] only 3% of adults with cancer take part in clinical trials.  Andy Miller, Vice President of Programs at the Lance Armstrong Foundation, says that there are huge issues with government websites that list clinical trials.  He says many don’t list exclusion criteria that would make a patient ineligible based on their diagnosis or previous treatments.  He also says that many of the sites post incorrect contact information or list trials that are not even seeking patients [and that this can] make for a really frustrating activity for [patients]….  Enter Emerging Med, an online and phone consultation service that’s been getting a lot of positive press.  Emerging Med is a ‘clinical trial matchmaker’ funded by pharmaceutical and biotech companies.  Emerging Med primarily works with cancer patients interested in taking part in clinical trials in the US and Canada.  The company works with advocacy organizations like the Lance Armstrong Foundation to further outreach.  ‘They’re able to help our constituents, [says Miller,] to focus their searches for clinical trials and to provide them with customized lists and contact information that we feel has a greater reliability and specificity than someone might find if they were just engaging in a search on the Web.’  A company spokesperson said Emerging Med will be moving into other arenas beyond cancer and is also working with health IT vendors, exploring the use of electronic medical records to identify patients who could benefit from a clinical trial.  That’s already happening at Holston Medical Group, a 140-physician group operating in 26 locations in Tennessee and Virginia.  The Group started using Allscripts’ TouchWorks™ electronic health record in 1996 to create a database that is used to alert physicians when they have a patient who could be eligible for a clinical trial. Their recruitment efforts brought in nearly $2.5 million last year from the pharmaceutical industry. […] Currently, the Holston Medical Group has patients enrolled in 100 clinical trials involving diseases such as diabetes, hypertension and emphysema….  Holston has spun off a separate company, One Partner Research, that’s in the process of establishing a central data repository and a region-wide effort working with other medical groups to reach out to patients.  Tom Deaderick directs One Partner.  He says pharmaceutical companies spend $514,000 a day [on Phase II and III trials].  He wants to help the drug companies to save money while helping medical groups to make money on the process.  ‘Long-term, [says Deaderick,] what I’d like very much like to do is to take the central data repository with the patient identities blinded, so that you’d have no access to the patient identities through the tools that we provide, but give the pharmaceutical companies the ability to input a series of parameters and to know how many patients – not who, not which patients – but how many patients they have as candidates in each of the groups that are members of One Partner.  And so we will have taken a maximum amount of cost and time out of the drug development process.’  One Partner will be sharing its experience with those involved in the Clinical Trials Transformation Initiative [(CTTI), the FDA’s new public-private partnership focusing on streamlining and modernizing clinical trials in the US].”   Listen to audio report   |   Visit Emerging Med website   |   Visit One Partner website

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Matchmakers: Patients Meet Clinical Trials

May 15, 2008

“With growing concern about a shortfall of patients to participate in clinical trials - especially adult cancer patients, minorities and adolescents - a number of new programs are stepping up efforts to match patients to trials and educate patients and their physicians about the benefits of medical research.  Large medical centers are developing their own Web sites to help inform and recruit trial patients locally. And nonprofit health organizations are reaching out to community groups to educate residents about clinical trials and help them navigate issues….  [According to a] survey by Harris Interactive, 85% of cancer patients were either unaware or unsure at the time of their diagnosis that participation in clinical trials was an option. Of those, 75% said they would have been willing to enroll had they known it was possible. [...] EmergingMed, a for-profit service that connects patients to cutting-edge clinical trials [is working to close this gap.]  EmergingMed gets paid through fees it charges medical centers, advocacy groups and research sponsors. The company doesn’t get paid to recruit patients, and doesn’t disclose personal information gathered on its site. On [May 14], Revolution Health will announce that it has partnered with EmergingMed to offer the service free on its site. EmergingMed’s Web tool, which is free for individuals, compares patients’ short personal profiles to the enrollment criteria for thousands of trials in minutes. [...] Emerging-Med consultants call patients who have registered with the service when new trials come up.” Read more

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Tectonic Shifts in the Health Information Economy

April 18, 2008

“In a recent shift in the health information landscape, large corporations are seeking an integral and transformative role in the management of health care information. The mechanism by which this transformation is likely to take place is through the creation of computer platforms that will enable patients to manage health data in personally controlled health records (PCHRs). Two types of large corporations are involved. [...] Technology companies such as Google and Microsoft see business opportunities, whereas Fortune 100 companies in their role as employers see efficiencies and cost savings when patients can securely store, access, augment, and share their own copy of electronic health information. Though this shift in the locus of control of health information is driven largely by a need to provide assistance with clinical care processes, it will also profoundly affect the biomedical research enterprise. [The article authors, Drs. Kenneth Mandl and Isaak Kohane, contend that] PCHRs are a disruptive innovation that inverts the current approach to medical records in that they are created by and reside with patients who grant permission for their use to institutions, clinicians, researchers, public health agencies, and other users of medical information. [...] How would this access be determined? One approach would be to allow individual patients to strictly control access to their data by third-party researchers. [...] Another approach would be for the platform company to directly extract data, perhaps de-identified, by polling across PCHRs, removing the patient as the intermediary in the decision. The latter approach is not consistent with a fully personally controlled model ... but it could well be chosen by some commercial vendors. [...] Our society should make an informed decision about how the goals of improving health care, and the twin beacons of maximizing patient autonomy while minimizing health risk, should be served in the context of a seismic change in the locus of control, curation, interpretation, and guardianship of patient information. The companies providing PCHRs are not covered entities under [HIPAA]. [...] Consumers navigating the opportunities to share and potentially even monetize their data for research deserve a guidepost such as a certification or a seal of approval with regard to services, software, and projects from a trusted authority. [...] Creative and effective online consent processes must be developed and used, since globalization of the research enterprise requires electronic means of researcher-subject interaction. Such consent must reveal clearly and emphatically how identified and de-identified patient data will be handled. [...] Despite these challenges, many consumers with PCHRs will soon control a valuable resource - an integrated copy (possibly the only such copy) of their health care information across sites of care and over time…. Under favorable conditions, consumers will benefit considerably as new business models develop, enticing them to engage in research, establishing communication channels between researchers and PCHR owners, and competing for consumer attention over those channels.”   Read more (paid subscription required)   |   Visit Harvard PCHRI home page

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Report Claims Clinical Trials Miss Many Populations

April 1, 2008

“A new analysis of the American clinical trial process suggests that the system for testing new drugs [has major deficiencies in the way trials are designed, carried out and funded in the US]. ‘We’ve got a big problem,’ said Daniel S. Goldberg, chief policy adviser for the report.  ‘And it’s extremely urgent that we fix it. Because we’re trying to figure out how to streamline health care and make people healthy, of course. And the fact that we have under-representation in clinical trials undermines both of these goals and undermines the quality of the evidence we come up with.’  The report was conducted by the Chronic Disease Prevention & Control Research Center at Baylor College of Medicine….  The team noted that about 80,000 clinical trials are conducted in this country each year, and that less than 1 percent of the American population - 2.3 million men and women - participate in such trials.”   Read more   |   Read White Paper

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Practicing Patients

March 24, 2008

“There are a little more than 7,000 [members of] PatientsLikeMe, congregating around diseases like Parkinson’s, multiple sclerosis (MS) and AIDS, all of them contributing their experiences and tweaking their treatments. The members of PatientsLikeMe don’t just share their experiences anecdotally; they quantify them, breaking down their symptoms and treatments into hard data [to generate] a rich database of disease treatment and patient experience.  [...] The Web site gathers patient information on two levels: first there’s a quantitative breakdown of symptoms and dosages, data that the software instantly turns into charts and graphs. Second are the forums, where members share advice and provide more nuanced feedback on a certain drug or treatment issue. [...] The company, which is financed by private investors, eschews advertising; the business model instead seeks to exploit the value of the databank itself. By and large, this means working with pharmaceutical companies. The company has had discussions with several drug firms to sell anonymized patient data on various symptoms and treatments. They have also recruited PatientsLikeMe members to be participants in clinical drug trials. [...] HIPAA satisfies no one - not the privacy advocates, who argue against most any form of electronic record, and not the medical researchers, who now face onerous restrictions on their work. PatientsLikeMe upends this dialectic; in technology terms, it routes around the problem. Since the company is an opt-in service and not a health-care provider, HIPAA doesn’t apply. Good thing, really, since the site identifies members’ cities and their ages, two of HIPAA’s 18 prohibited categories of personal information. [T]he company’s Openness Philosophy, a manifesto posted prominently on the site, [states:]  ‘Currently, most health-care data is inaccessible due to privacy regulations or proprietary tactics[.] As a result, research is slowed, and the development of breakthrough treatments takes decades…. When you and thousands like you share your data, you open up the health-care system…. We believe that the Internet can democratize patient data and accelerate research like never before.’ [...] Since PatientsLikeMe forgoes advertising, selling its data to pharmaceutical companies is its best apparent way to make money. But so far, it seems, the drug industry has balked at the prospect of knowing so precisely what happens to their products after they reach the market.”   Read more   |   Visit PatientsLikeMe website

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Clinical Data as the Basic Staple of Health Learning: Creating and Protecting a Public Good

February 29, 2008

On February 28-29, 2008, as part of the IOM Roundtable on Evidence-Based Medicine, Dr. Alan F. Westin chaired a Workshop panel focusing on Privacy and Security Issues, at which time he presented an updated version of his 2007 IOM-sponsored survey.  In his updated Survey Report, Dr. Westin states: “Our results confirmed ... that large majorities of the public continue to hold strong privacy perspectives in the handling of their PHI, especially when secondary uses are involved. Our survey found that 58% of the public does not believe that federal and state laws and organizational practices provide enough privacy protection today for consumers’ personal health information. [...] This suggests that any set of solutions to the process of obtaining PHI for health studies will have to find ways to meet – and satisfy – the privacy and data security concerns of a rather skeptical public majority. It also suggests to me, apart from the IOM project, that writing up-dated health privacy protections for when health care reform is taken up in the next Congress, or when federal funding for EHR programs is considered, will draw a strong advocacy drive and much public support. [...] Many health researchers see [ ] ‘health data mining’ as a major goal for health research in the coming decades. However, getting such uses accepted would, I believe, require institutionalizing the two fundamental conditions that the IOM survey documented as majority public conditions – description of the studies to be undertaken and an individual choice mechanism – whether an opt-out or an opt-in. If notice and a choice mechanism were acceptable to EHR/PHR participants, there could even be solicitation of a general advance acceptance by individuals to have their PHI used – with anonymity assured and IRB review – for designated classes of health studies and by specified types of researchers.”    Read more   |   View Agenda   |   View IOM Workshop Slides   |   View Original Report   |   View Updated Report

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IOM Project Survey Findings on Health Research and Privacy

December 13, 2007

Dr. Alan Weston’s presentation at the Fifteenth National HIPAA Summit in Washington, D.C., referencing findings from a survey of consumers commissioned by the Institute of Medicine (IOM), the interviews for which were conducted in September 2007.  According to Dr. Westin (at 39:30 – 41:40 of the video): “What our survey helps to understand is that there is a public frame of mind that you have to take as the reality.  The reality is that trust in health researchers and a willingness to have information used without the notice and consent elements will not be bought by the American public.”   View Video Presentation   |   View IOM Workshop Slides   |   View Dr. Westin’s Survey Report

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Threats to Your Genetic Privacy

November 16, 2007

“[T]he overwhelming majority of Americans agree on one thing: Your genes are your own business and should not be tapped by employers or health insurers deciding whether you or your family are fit for their company. [These] privacy concerns are no longer abstract. Francis Collins, director of the National Human Genome Research Institute, will tell you the worry out there is real. To protect their privacy, some patients use assumed names when tested for breast cancer genes or ask their doctors to lie for them about positive disease-related gene results so insurance companies won’t know. Lots of others don’t even seek their genetic info for this reason. NIH has shown that nearly half of family members at high risk for inheriting a cancer-producing mutation were unwilling to participate in any part of a clinical study because of a fear of genetic discrimination. In fact, no one is really spared this worry.” Read more

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Researchers complain of privacy rules: Health privacy rule is ‘impeding research’

November 14, 2007

“Biomedical research in the United States has suffered substantial adverse effects from a rule on patient privacy introduced in 2003, according to concerned scientists…. Crucially for researchers, [HIPAA] allows disclosure of records for research only if the researcher in question has obtained authorization from each patient or obtained a waiver from an institutional review board. While researchers applaud the goal of protecting privacy, they say the paperwork involved with the HIPAA rule is slowing and impeding research. [...] In [responses to a] survey, published in the [Nov 14, 2007 issue of] Journal of the American Medical Association (JAMA), 68% of epidemiologists agreed with the statement that research has been made more difficult by HIPAA…. The respondents represent as many as one in eight US epidemiologists, according to Ness, who conducted the research for the Societies of Epidemiology and was funded by the National Academy of Sciences’ Institute of Medicine.”   Read more   |   Read JAMA article (subscription required)

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Medical Privacy Rule May Hurt Research

November 14, 2007

“A federal patient privacy rule has had a chilling effect on medical research, making it tougher to recruit patients and use their health records, the first national survey on the topic suggests. [In a survey commissioned by the Institute of Medicine,] two-thirds of the more than 1,500 epidemiologists surveyed said the Health Insurance Portability and Accountability Act, also called HIPAA, has made their research more difficult. [...] A privacy advocate said the protections offered by HIPAA are needed and desired by patients. ‘The public DOES overwhelmingly support research but not without consent,’ said Dr. Deborah Peel of the Patient Privacy Rights Foundation, a watchdog group…. Most Americans want to know how their personal medical records are used in research and want to be asked for their consent before those records are used, Peel said.”   Read more   |    Read coverage in Forbes   |   Read coverage by Reuters

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Ask and ye shall receive: Striking a balance between privacy and health

October 22, 2007

“Many Americans will do their part when asked to allow their heath records to be used for medical research, but the operative phrase is ‘when asked.’  And, for a plurality of those who do volunteer, that means being asked each and every time their records are to be used, according to a [study] presented [by Alan Westin] during two days of meetings [on October 1-2, 2007] before [an IOM] Committee on Health Research and the Privacy of Health Information….  78% of respondents indicated that they were interested in reading or hearing about new health research studies [but] obtaining patient consent, at least in some form, was a threshold requirement for research project participation in which personal information was disclosed, according to an overwhelming majority of participants in Westin’s survey. Only 1% of participants agreed that researchers would be free to use their health information without their consent while just 8% indicated an initial, ‘general consent’ given in advance would suffice to have researchers use their information in future research projects without having to contact them.”   Read Part 1   |   Read Part 2   |   Read about IOM committee   |   View IOM Survey Results   |   View Presentation Summarizing Results

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The Autonomy Trap

August 24, 2007

“[The legal] focus on notice and choice has clearly led to a migration away from substantive protections for privacy in favor of procedural ones. [...] Choice is increasingly becoming an illusion [and] blanket consent ... choice is meaningless.  [...] This critique is especially acute in the area of healthcare [ ] for a number of reasons, the most important of which is the focus on autonomy, which in the US lies at the heart of medical care and medical research.  [This problem has] found its highest expression in the US in HIPAA [which] has proven problematic in practice [and which] exempt[s] most of the disclosures that people might regard as effecting their privacy. [And yet the law currently inhibits access to] patient data [that] is a critical resource to research and ... to finding research subjects.  [For] example:  Eli Lily was developing inhalable insulin [and] one of the concerns raised by the FDA was ‘how was inhalable insulin going to work for people with asthma or with other forms of chronic obstructive pulmonary disease?’  So the FDA wanted Lily to do a study on diabetics who had asthma but, by the way, who had not smoked.  But since smoking is a major contributor to asthma and the largest cause of [COPD], it was a major burden to find the research subjects and that of course is done with access to data. [Moreover, it’s] not just about what we’re doing today, it’s where the future of medicine is going that should be our concern….  Personalized medicine is all the talk at the NIH, FDA and HHS.  It means a lot of things, but all of these things require access to personal data…. The problem we have - as everyone acknowledges - is privacy law [where] we’ve imposed this consent requirement so that before somebody can look at your data ... there first must be compliance with HIPAA and other applicable laws.  One way that HIPAA allows for this is by using de-identified data [which] requires removing [key] data elements that would be necessary to do the research.  [...] The other primary way [is to get] consent from the data subject [or] approval of an institutional review board (IRB).  I have neither time nor do I think it’s necessary to belabor all of the difficulties in getting consent from patients.  It is very, very difficult….  [On the other hand,] the law is not very permissive [pertaining to IRBs]....  [Whether or not we eliminate the legal requirements for attaining] consent, it is inescapable that we are going to have to develop stronger, more substantive tools for protecting privacy [since] the one point on which everyone ... agrees is that public trust is critical to support this type of research. [...] Privacy control is just no longer realistic; it’s no longer appropriate; and in many cases, it is no longer desirable.  It creates an impossible burden for individuals for us to say to them: ‘Here, you exercise control over your own data.’  Increasingly, it cannot be done.  We know it.  And it’s high time we admit it and begin searching for better, more substantive protections for personal privacy instead.”  See video of presentation

Obtaining Medical Records from Healthcare Facilities under the HIPAA Privacy Rule

May 29, 2007

“Longitudinal cohort studies often rely on timely retrieval of participants’ medical records of hospitalization and doctor’s office visits.  Because the information in medical records is personal health information with attendant confidentiality issues, record retrieval has always been a challenging process. [...]  Under [HIPAA regulations], study consent processes must now include separate permission for the release of medical record information.  [This study] examined the response rates, correlates of response rates, and response times for obtaining patient medical records from healthcare facilities [and found that] a majority of healthcare facilities are willing to release participant medical information to a research study when appropriate permission is included. [...] Designing [such a form] is essential.”  Read more (Paid subscription to Neuro-epidemiology required)

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Protecting Privacy and Encouraging Research: Are These Conflicting or Complementary?

June 1, 2005

“Congress and regulatory agencies are attempting to balance the rights of patients to control the use of their identifiable health information with the need for medical progress to continue through human subject research. Because of the accommodation to research in HIPAA, there are many routes by which a desired research goal can be accomplished—without unduly jeopardizing the patient’s privacy.” Read more

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