Portuguese Interoperabilty

Source: Diario da Republica 1. Series – n.118 – 21st June 2011, Portuguese Parliament Law n. 36/2011, Unofficial translation


The Portuguese law defines interoperabilty as follows:


Article 1  Object
"The present act establishes the adoption of open standards for digital information in the Public Administration, promoting technological freedom of the citizens and organizations and interoperability of the State information systems."




"For the purposes of the present act, “interoperability” is considered to be the capacity of two or more systems, such as computers, media, networks, software and other components of information technology, to interact and exchange data according to a defined method aimed at obtaining the expected results."


Article 3 Definition:


"1 – For the purposes of the present act, “open standard” is considered to be the technical manner in which to publish, transmit and store information in digital format fulfils cumulatively the following requirements:
  a) Its adoption derives from a transparent decision process, available to the participation of all interested parties;
  b) Its respective specifications document has been published and is freely available, with no restrictions to its copy, distribution and utilization;
  c) Its respective specifications document does not incite cover non-documented actions or processes;
  d) Its applicable Intellectual Property Rights, including patents, has been made available wholly, irrevocably and irreversibly to the Portuguese State.
  e) There are no restrictions to its implementation."

VA Challenge to RTLS Award

I contacted the Veteran's Administration today.  I asked for the following information.
1.  The number of protests
2.  Who has filed a protest?
3.  The nature of each protest


No answer yet.  I will keep you informed.

Stand-Alone Software and Unique Identifiers

Though section 614 of the new American law does not mention Unique Device Identifiers as a requirement for certain software applications, I found a reference in Federal Register Vol. 77, No. 132  Tuesday July 10, 2012, Proposed Rules.  The word device in the law covers certain software applications per § 201(h) of the FD&C Act.


From Page 40741
Ensuring the accurate identification of certain devices, even when the device is separated from its label and package.  The rule would require some devices to be directly marked with a UDI, so that it will always be possible to positively identify the device, regardless of how long the device remains in use. These devices, by their intended or customary use, are typically separated from the labeling that accompanies delivery of the device to users:
• An implantable device;
• A device that is intended for more
than one use and to be sterilized before
each use; and
• Stand-alone software.

BILL S,3187 SEC. 614. UNIQUE DEVICE IDENTIFIER

SEC. 614. UNIQUE DEVICE IDENTIFIER.
Section 519(f) (21 U.S.C. 360i(f)) is amended—
(1) by striking ‘‘The Secretary shall promulgate’’ and
inserting ‘‘Not later than December 31, 2012, the Secretary
shall issue proposed’’; and
(2) by adding at the end the following: ‘‘The Secretary
shall finalize the proposed regulations not later than 6 months
after the close of the comment period and shall implement
the final regulations with respect to devices that are
implantable, life-saving, and life sustaining not later than 2
years after the regulations are finalized, taking into account
patient access to medical devices and therapies.’’.

Interoperability - Portugal IT Open Standards From EU Joinup.

The following link is from European Commission Join Up.   Their post includes coverage from TEK, a Portuguese IT new site.   I am still looking for the final version of the actual law, preferably an English Translation.  PT: Open standards become prerequisite for government IT | Joinup

Internet and interoperability Summary - S, 3187

Recent statements from the FDA on Unique Identifiers sent me on a search for S, 3187.  Govtrack.us shows the bill as signed.  The Library of Congress shows the Bill is now public law 112-144.  I found the information on unique identifiers and continued to read.  I found Internet and  Interoperability  Guidance tucked away at the end of S3187.  The sections are 1121, 1122, and 1141.     

SEC. 1121. Guidance Document Regarding Production Promotion Using The Internet

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.

SEC. 1122. COMBATING PRESCRIPTION DRUG ABUSE.

(b) REPORT.—Not later than 1 year after the date of enactment of this Act, the Secretary shall post on the Department of Health and Human Service’s Internet Web site a report on the findings S. 3187—121 of the review under subsection (a). Such report shall include findings and recommendations on—

b(2).  how best to develop and disseminate widely best practices models and suggested standard requirements to States for achieving greater interoperability and effectiveness of prescription drug monitoring programs, especially with respect to provider participation, producing standardized data on adverse events, patient safety, and patient outcomes;

SEC 1141 Recommendation on Interoperability Standards

(a) IN GENERAL.—The Secretary of Health and Human Services may facilitate, and, as appropriate, may consult with the Attorney General to facilitate, the development of recommendations on interoperability standards to inform and facilitate the exchange of prescription drug information across State lines by States receiving grant funds under—

Excerpts - S, 3187 Internet and Interoperability

SEC. 1121. Guidance Document Regarding Production Using The Internet

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.

SEC. 1122. COMBATING PRESCRIPTION DRUG ABUSE.

(a) IN GENERAL.—To combat the significant rise in prescription drug abuse and the consequences of such abuse, the Secretary of Health and Human Services (referred to in this section as the‘‘Secretary’’), in coordination with other Federal agencies, as appropriate,shall review current Federal initiatives and identify gaps

and opportunities with respect to—

  (1) ensuring the safe use of prescription drugs with the potential for abuse; and

  (2) the treatment of prescription drug dependance.

(b) REPORT.—Not later than 1 year after the date of enactment

of this Act, the Secretary shall post on the Department of Health

and Human Service’s Internet Web site a report on the findings

S. 3187—121 of the review under subsection (a). Such report shall include findings

and recommendations on—

  (1) how best to leverage and build upon existing Federal and federally funded data sources, such as prescription drug monitoring program data and the sentinel initiative of the Food and Drug Administration under section 505(k)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), as it relates to collection of information relevant to adverse events, patient safety, and patient outcomes, to create a centralized

data clearinghouse and early warning tool;

  (2) how best to develop and disseminate widely best practices models and suggested standard requirements to States for achieving greater interoperability and effectiveness of prescription drug monitoring programs, especially with respect to provider participation, producing standardized data on adverse events, patient safety, and patient outcomes; and

  (3) how best to develop provider, pharmacist, and patient education tools and a strategy to widely disseminate such tools and assess the efficacy of such tools.

(c) GUIDANCE ON ABUSE-DETERRENT PRODUCTS.—Not later than

6 months after the date of enactment of this Act, the Secretary

shall promulgate guidance on the development of abuse-deterrent

drug products.

SEC 1141 Recommendation on Interoperability Standards

(a) IN GENERAL.—The Secretary of Health and Human Services may facilitate, and, as appropriate, may consult with the Attorney General to facilitate, the development of recommendations on interoperability standards to inform and facilitate the exchange of prescription drug information across State lines by States receiving grant funds under—

  (1) the Harold Rogers Prescription Drug Monitoring Program established under the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2002 (Public Law 107–77; 115 Stat. 748); and

  (2) the Controlled Substance Monitoring Program established under section 399O of the Public Health Service Act (42 U.S.C. 280g–3).

(b) REQUIREMENTS.—The Secretary of Health and Human Services  shall consider the following in facilitating the development of recommendations on interoperability of prescription drug monitoring programs under subsection (a)—

  (1) open standards that are freely available, without cost and without restriction, in order to promote broad implementation; S. 3187—135

  (2) the use of exchange intermediaries, or hubs, as necessary to facilitate interstate interoperability by accommodating State-to-hub, hub-to-hub, and direct State-to-State communication;

  (3) the support of transmissions that are fully secured as required, using industry standard methods of encryption, to ensure that protected health information and personally identifiable information are not compromised at any point during such transmission;

  (4) access control methodologies to share protected information solely in accordance with State laws and regulations; and

  (5) consider model interoperability standards developed by the Alliance of States with Prescription Monitoring Programs.

(c) REPORT.—

  (1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on enhancing the interoperability of State prescription drug monitoring programs with other technologies and databases used for detecting and reducing fraud, diversion, and abuse of prescription drugs.

  (2) CONTENTS.—The report required under paragraph (1) shall include—

    (A) an assessment of legal, technical, fiscal, privacy, or security challenges that have an impact on interoperability;

    (B) a discussion of how State prescription drug monitoring programs could increase the production and distribution of unsolicited reports to prescribers and dispensers of prescription drugs, law enforcement officials, and health professional licensing agencies, including the enhancement of such reporting through interoperability with other States and relevant technology and databases;

    (C) any recommendations for addressing challenges that impact interoperability of State prescription drug monitoring programs in order to reduce fraud, diversion, andabuse of prescription drugs; and

    (D) an assessment of the extent to which providers use prescription drug management programs in delivering care and preventing prescription drug abuse.

Source:http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf

Stanley Healthcare Solutions, Update July 6, 2012

To my faithful blog readers, I truly appreciate your support and feedback.  To my new readers, guests, and even those who just happen to pull up my page, thanks.  I appreciate your interests. 

Asset Management for Healthcare continues to follow and recap significant events concerning the  Stanley Black and Decker acquisition of Aeroscout.  The blog has consistently led announcements concerning the acquisition.  Here are quotes from some prior posts relevant to the latest news.  Please check the blog archives to read the related threads.

May 21, 2012 -Moving down to where Aeroscout may fall, I found no list of who directly manages Stanley Healthcare Solutions (SHS) - no general manager, no CEO, no SVP.  There were no links back to the Stanley Black and Decker website, either.

May 24, 2012 - So, what’s the best structure to work out those redundancies and what part will Aeroscout play in the streamlining the hardware, software and professional services?  Perhaps this is where the reports of having Aeroscout to act as a research and development center may come into play.  Or will InfoLogix take that lead?  We will find out soon enough.

In saying that, I am more curious to learn whether Stanley Healthcare Solutions will continue to fall under Stanley Black and Decker’s security segment.

First, let’s answer the question of whether a Stanley Black and Decker senior executive would emerge as clearly the person in charge of Stanley Healthcare Solution?   And the answer is … yes.  Bert Davis is now the Senior Vice President and President of  Stanley Healthcare Solutions.   His previous title was Chief Information Officer/SFS (The Stanley Fulfillment System).  This appears to mean that Stanley Healthcare Solutions no longer falls under the security sector.  So, 2 questions from the previous blog posts are answered.

The question of what’s the best structure to work out the hardware, service, and application redundancies, that structure is clearly The Stanley Fulfillment System.  The Stanley Fulfillment System is more than a business unit.  It is a philosophy and a practice that drives operational improvement, profitability, and value to the customer.  This includes streamlining technology platforms which leads to more understandable solutions for the customer.  That means a clearly defined mission and additional resources for the Chief Technology Officer.

In other words, a great deal of that focus and resources may be headed straight for Stanley Healthcare.  The amount of the load, C-23 Sherpa, C-130 Hercules, or C-17 Globemasters’ worth…?  We will have to assess that in the future.

Then… there is the matter of Joel Cook’s new position.  He is now the Director of Healthcare.  His former public profile stated Sales Director, West Region Healthcare for Aeroscout.   Joel was one of the positive influences I encountered during the project of which I wrote about in my book, Covering Your Assets By Exposing The Butt-Ugly Truth.  He has the ability to leave an executive sales meeting and walk right into to dicey implementation and straighten it out, including troubleshooting why different technologies are not producing the desired outcome.  I am not saying that there aren’t other sales and marketing types who can do the same.  In fact, I know that there are others.  I am just pointing out that I believe he understands the RTLS environment as it relates to healthcare along with the variety of technologies and techniques we need.  He is teamed up with a former CIO deeply involved in The Stanley Fulfillment System.  It shows that Stanley did not just buy a company and put the plans for it on the back burner.

Here is the recount: The Stanley Fulfillment System, a single, clearly identifiable leader, the realignment of Bert Davis and Joel Cook, possibly a research center sitting in Israel and Stanley Healthcare Solutions seems to no longer fall under the Security Segment.  I am not sure who makes up the rest of the team but my overall impression - this is a positive directional shift for Stanley Healthcare Solutions.

Will the team meld into one?  How long will it take the new 

leaders to drive the hardware, service, and applications 

through The Stanley Fulfillment System?  We will have to 

track that as well.