Tags |
|
|
Links |
|
|
Top Articles - HIPAA and Email - How Does Your Practice Deal with Compliance in a Digital Age?
The internet has created a new business model for the smaller medical practice, specialty clinic and medical service (e.g. dermatologist, plastic surgeon, physical therapist, psychologist, et. al). More and more, patients are looking to communicate with their healthcare providers as they do in their personal and business
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
lives – via email.
Email as a communication solution for the smaller clinic can be a time-saving resource. It can replace the many phone calls and postal mailings, adding a financial benefit to the smaller clinic.
Does email eliminate the office visit? No, nothing can replace the personal face-to-face office visit, bu
Email as a communication solution for the smaller clinic can be a time-saving resource. It can replace the many phone calls and postal mailings, adding a financial benefit to the smaller clinic.
Does email eliminate the office visit? No, nothing can replace the personal face-to-face office visit, bu
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
email can be an additional tool clinicians can implement to streamline their practice.
Some healthcare practitioners do however feel that emailing their patients equates to working for free, but some clinics have already adopted charging for email consultations.
At some practices, patients pay a flat rate from $100 to
Some healthcare practitioners do however feel that emailing their patients equates to working for free, but some clinics have already adopted charging for email consultations.
At some practices, patients pay a flat rate from $100 to
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
everal hundred dollars per year for this type of service. Harvard professor of medicine Dr. Daniel Z. Sands, a proponent to a digital clinic, stated "I think it’s reasonable to assume that if lawyers and accountants charge for time, then physicians should too. (1)"
Sustainability of Health Information Technology is also
Sustainability of Health Information Technology is also
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
on the government's radar. As part of the President's mandate to move the medical field towards a digital clinical setting within the next ten years (2). The National Coordinator for Health IT, Dr. David Brailer, noted the value-added benefit of investing in Healthcare IT:
Information technology supports
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
reatment choices for consumers and enables better and more cost-effective care... Health IT not only adds value to the way people lead their lives, but it gets more out of our investment in healthcare overall. (3)
It is possible for clinics to shift towards a digital medical office while remaining financi
It is possible for clinics to shift towards a digital medical office while remaining financi
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
ally solid. Rights management software tools have become a reality for the small and medium business office (4). Small Business Rights Management (SBRM) reflects a shift Rights Management software tools.
SBRM solutions provide clinics and practices of a smaller scale an equal level of user rights management and encrypt
SBRM solutions provide clinics and practices of a smaller scale an equal level of user rights management and encrypt
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
on previously available to larger medical organizations (e.g. state hospitals, large research facilities, university medical networks, etc.).
With any medical advance, the side affects of a solution or cure, must also be considered. While email is beneficial time-wise and financially, there are also cons to using this t
With any medical advance, the side affects of a solution or cure, must also be considered. While email is beneficial time-wise and financially, there are also cons to using this t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ol – many HIPAA related. According to the Health Privacy Project's 2005 study, 70% of Americans are concerned that personal health information (PHI) could be disclosed as a result of weak data security (5)
Currently, healthcare organizations are required to provide a disclosure statement when communication is sent to th
Currently, healthcare organizations are required to provide a disclosure statement when communication is sent to th
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ir patients. A sample of a healthcare professional’s email disclosure statement may read like this:
Client information gathered by [Clinic or Organization's Name] is protected by Federal Law. If this communication contains any client information, including information which would identify a client, you are prohibited f
Client information gathered by [Clinic or Organization's Name] is protected by Federal Law. If this communication contains any client information, including information which would identify a client, you are prohibited f
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
om redisclosing it to any person or organization in any manner, and you are required to maintain it as confidential. Failure to do so is punishable by civil and criminal penalties. If such information has reached you in error, please contact [Clinic or Organization's Name] contact@emailaddress.com
With the advent of phi
With the advent of phi
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
shing, malware, and spyware, the unintended recipient could possibly spread a patients PHI like a virus; using or selling data to any number of damaging sites.
Protecting a patient's PHI is an ingrained concept within the medical profession. Laws and government mandates are take this notion a step further, medical facil
Protecting a patient's PHI is an ingrained concept within the medical profession. Laws and government mandates are take this notion a step further, medical facil
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ties not compliant to protecting their patient’s PHI face stiff penalties under HIPAA. PHI includes and is not limited to:
- Patient's address, phone number
- Treating Hospital/Clinic number assigned the patient
- Patient's date of birth/ SSN
- Patients legal next of kin/guardian and
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
heir telephone number
Patient's insurance information (pre-certification/ DSHS/ Medicare)
Anticipated Admission date and time
While there are some drawbacks to email, patients want the option of emailing their doctor, pharmacist, therapist or clinic. "People are often more comfortable t
While there are some drawbacks to email, patients want the option of emailing their doctor, pharmacist, therapist or clinic. "People are often more comfortable t
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
lking to a computer than they are to a doctor," said Dr. Delbanco, a professor of medicine at the Harvard Medical School and the lead author of an article on doctors and e-mail in the New England Journal of Medicine (6).
Dealing with HIPAA compliance issues can often be frustrating to the small clinical practice. SBRM s
Dealing with HIPAA compliance issues can often be frustrating to the small clinical practice. SBRM s
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
lutions bridge the gap between staying current with healthcare industry regulations and keeping a small physician practice open. Patient/client information, private communiqu? regarding diagnosis/treatment, and medical billing can stay discreet, only the intended recipient will see this information.
With SBRM solutions;
With SBRM solutions;
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
clinics don't have to worry that their email content breaks the Hippocratic Oath's creed of confidentiality by revealing patient's PHI. Healthcare providers can remain both respectful and compliant under HIPAA regarding the patient privacy.
- - - - - - - - - -
End Notes:
1.) Dr. Daniel Z. Sands as quoted in Liz Kowalc
- - - - - - - - - -
End Notes:
1.) Dr. Daniel Z. Sands as quoted in Liz Kowalc
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
yk's article "Is E-Mailing the Future of Doctor-Patient Relations?" The Boston Globe, D2, April 27, 2004, Lexis Nexus – http://www.lexisnexus.com
2.) United States Department of Health and Human Services, "Secretary Leavitt Takes New Steps to Advance Health IT," Press Release on HHS website, June 6, 2005, http://www.os.d
2.) United States Department of Health and Human Services, "Secretary Leavitt Takes New Steps to Advance Health IT," Press Release on HHS website, June 6, 2005, http://www.os.d
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
hs.gov/
3.) "Remarks by David Brailer, MD PhD National Coordinator for Health Information Technology HIMSS 2005" February 17, 2005, http://www.himss.org
4.) SBRM on Wikipedia - http://en.wikipedia.org/wiki/Small_Business_Rights_Management
5.) "Majority of Americans Have Privacy Concerns about Electronic Medical Record
3.) "Remarks by David Brailer, MD PhD National Coordinator for Health Information Technology HIMSS 2005" February 17, 2005, http://www.himss.org
4.) SBRM on Wikipedia - http://en.wikipedia.org/wiki/Small_Business_Rights_Management
5.) "Majority of Americans Have Privacy Concerns about Electronic Medical Record
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ystem," Health Privacy Project (www.heathprivacy.org): http://www.healthprivacy.org/info-url_nocat2303/info-url_nocat_show.htm?doc_id=263085
6.) Anahad O'Connor, "Take Two Aspirin, E-Mail Me Tomorrow," The New York Times, Section F; Column 5; Health & Fitness; 7., September 2005, Lexis Nexis - http://www.lexisnexus.com 3
6.) Anahad O'Connor, "Take Two Aspirin, E-Mail Me Tomorrow," The New York Times, Section F; Column 5; Health & Fitness; 7., September 2005, Lexis Nexis - http://www.lexisnexus.com 3
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.toparticles.org.ua/article/131324/toparticles-HIPAA-and-Email--How-Does-Your-Practice-Deal-with-Compliance-in-a-Digital-Age.html">HIPAA and Email - How Does Your Practice Deal with Compliance in a Digital Age?</a>
BB link (for phorums):
[url=http://www.toparticles.org.ua/article/131324/toparticles-HIPAA-and-Email--How-Does-Your-Practice-Deal-with-Compliance-in-a-Digital-Age.html]HIPAA and Email - How Does Your Practice Deal with Compliance in a Digital Age?[/url]
Related Articles:
Wholesale Dropshippers - How to Find The Best Wholesale Drop Shippers And Product Suppliers
The Evolution of Google AdSense
10 Steps for Cost Efficient Traffic-Building
Bookmark it:
|